Clinical Operations

Clinical Operations

The clinical operations function of a company is all about organisation, and optimising this function is key to the delivery of clinical trials โ€“ without a functioning clinical operations team no clinical research activity could be delivered. There are more than 300,000 clinical trials ongoing worldwide at any time, so effective clinical operations could save a lot of time and money in the drug development process.Since 2004, clinical trials in Germany have to be approved by the respective competent federal higher authority (depending on the type of product, either the BfArMor thePEI). This approval is required in addition to the favourable opinion from the competent Ethics Committee.

Clinical trials are a necessity for the treatment, diagnosis and prevention of diseases, but recruiting patients to conduct them can prove to be a challenge for clinical operations teams. Quantitative studies conducted found that 11% of investigative sites failed to enrol a single patient. In a way to combat this, clinical operations teams are turning to social media to recruit patients for their trials.A study of 20 leading pharmaceutical companies including Lilly, Pfizer and Novartis has shown how some have already piloted or tapped into social media with good results, with the report finding the number of patients being recruited on social media is increasing by 11%, year on year.

The payoff to a career in clinical operations is, of course, the satisfaction that comes with being involved in potentially lifesaving research, and enticingly most people working in clinical operations are usually paid excellent remunerations due to the importance of their role and the responsibility it carries. Clinical operations is a vital part of the global healthcare business intelligence market โ€“ a market that is expected to reach โ‚ฌ9.6bn by 2025, registering a CAGR of 12.8% during this period.

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Clinical Operations Jobs

Sr. Clinical Trails Manager

Senior Clinical Trial Manager Remote (USA) $135,000 - $160,000 Job Description EPM is partnered with a very exciting clinical stage biotechnology company that is focused on changing the landscape of Neuropsychiatric and CNS disorders. With a drug that is already approved on the market with potential to be a blockbuster, they have ample revenue coming in while still developing 8 new assets. Several of those are in Phase 3 now with a high chance of success, giving you the opportunity to join at a very exciting time. This is a very high potential opportunity with not only room for financial benefits, but tons of room for professional growth and organic vertical mobility. If you want to join a company that has the stability of large pharma, but the opportunity of small biotech, apply now. Key Qualifications A preference for a Bachelor's degree in the field of Life Sciences Experience relevant to the role spanning 5-6 years Proficiency in GCPs, designing clinical trials, understanding statistics, navigating regulatory procedures, and comprehending global clinical development procedures is required Capable of handling multiple tasks concurrently Demonstrates flexibility in response to alterations Maintains composure when faced with challenging situations Roles and Responsibilities Supervise, execute, and oversee the performance of CRO/Phase 1 Unit and/or third-party vendors to ensure adherences to SOPs and compliance with the defined scope of work within specified timelines and budgets Monitor operational study timelines and assess operational performance metrics throughout the study Ensuring the CRO(s) provide timely input and produce documents as per protocol and study plans Oversee CRO study start up activities and collaborate with various functional groups to guarantee timely collection of essential site documents and initiation of sites according to the study plan Holds primary responsibility for the timely, cost-effective, and high quality delivery of operational study objectives, with a global perspective Takes independent leadership in crafting the clinical study plan, outlining critical path activities and managing assigned clinical study(s) Leads the review and coordination for documents related to the protocol and its amendments

Negotiable
United States of America
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Senior CRA

Senior CRA Philadelphia, PA (Hybrid) $115,000 - $135,000 Job Description EPM is partnered with a cutting-edge biopharmaceutical firm with a focus on creating small-molecule and protein treatments for both orphan and high-value indications that target cancer, immune disorders, and inflammatory illnesses. They are utilizing cutting edge science and technology to alter the future of healthcare and the lives of their patients by merging AI-driven diagnostics to personalize patient data. To handle their products while they are still in the clinical stages and assist with vendor interactions, they are looking to hire a CTM/Senior CTM. To guarantee that clinical studies are carried out on schedule, you will collaborate cross-functionally with internal team members, vendors, and clinical study sites. Key Qualifications Extensive experience as a Clinical Research Associate (CRA), demonstrating in-depth knowledge of clinical trial processes, protocol adherence, and proficiency in monitoring activities. Regulatory Compliance: A solid understanding of regulatory requirements governing clinical trials, ensuring adherence to ethical and legal standards in all aspects of trial conduct. Site Management Skills: Proven ability to effectively manage and build relationships with clinical trial sites, ensuring efficient communication, compliance with protocols, and resolution of site-specific issues. Data Management Proficiency: Strong skills in data review, source data verification, and query resolution, ensuring the accuracy and integrity of clinical trial data. Communication and Collaboration: Excellent communication skills with the ability to collaborate cross-functionally, fostering positive relationships with investigational sites, sponsors, and internal teams to ensure successful trial execution. Roles and Responsibilities Site Management and Monitoring: Oversee and conduct on-site and remote monitoring activities, ensuring that investigational sites adhere to protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. Data Quality Assurance: Implement rigorous data review and source data verification processes, identifying discrepancies and ensuring the accuracy, completeness, and integrity of clinical trial data. Relationship Building: Cultivate strong relationships with investigational sites, establishing effective communication channels, addressing site-specific needs, and promoting a collaborative environment to optimize site performance. Regulatory Compliance: Ensure that all aspects of the clinical trial adhere to regulatory requirements, ethical standards, and company procedures, collaborating with regulatory affairs and addressing any compliance-related issues. Risk Mitigation and Issue Resolution: Proactively identify potential risks in the conduct of clinical trials and implement strategic plans for risk mitigation. Address and resolve issues promptly, ensuring the smooth progression of the trial and adherence to timelines. Benefits Medical Dental 401(k) PTO

US$115000 - US$135000 per year
United States of America
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Associate Director Clinical Operations

Salary: $190,000-$215,000 Associate Director Clinical Operations Boston, MA (Hybrid) Job Description EPM is partnered with a cutting-edge biotech firm at the forefront of revolutionizing autoimmune disease treatment. Leveraging groundbreaking advancements in immunology, their proprietary therapies target the root causes of autoimmune disorders, providing unprecedented precision and efficacy. They are dedicated to transforming lives by developing innovative solutions that not only alleviate symptoms but also halt disease progression. With a commitment to scientific excellence, the team is poised to redefine the landscape of autoimmune healthcare, offering hope and relief to millions worldwide. Join the team in shaping the future of autoimmune disease management and ushering in a new era of well-being. Responsibilities Identify and proactively address potential risks and issues in clinical trials, implementing mitigation plans to ensure trial success Provide leadership and mentorship to clinical operations teams, fostering a collaborative and high-performance work environment while managing and developing talent within the department Collaborate with cross-functional teams to develop and execute clinical trial strategies aligned with the company's goals and objectives Ensure that all clinical operations comply with regulatory requirements and industry standards, maintaining the highest quality standards in study conduct and documentation Oversee relationships with CRO's, vendors, and external partners, ensuring their performance aligns with project objectives and budgets Qualifications 8+ years of hands-on experience in clinical operations within the biotech or pharmaceutical industry, including direct involvement in planning and managing clinical trials A deep understanding of autoimmune clinical trials, including knowledge of the unique challenges and considerations associated with these trials, is highly desirable At least a bachelor's degree in a relevant life sciences field Excellent verbal and written communication skills, including the ability to convey complex scientific and clinical information to both technical and non-technical stakeholders Proficiency in regulatory compliance and an in-depth understanding of international regulations and guidelines related to clinical trial conduct Benefits Medical, dental, vision insurance 401(k) PTO and Holidays

Negotiable
United States of America
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Executive Director, Clinical Operations

Salary: $275-300K Company Summary: Helping a precision IO biotechnology company to build out their clinical operations team and they are currently looking for an Executive Director of Clinical Operations to head up their clinical operations team on a hybrid capacity in their SF office. Their mission is to develop best-in-class immunotherapies to address unmet needs within the oncology and their pipeline consists of 1 Phase I asset and 4 more preclinical assets and the Director/Senior Director will be a key leader in the oversight and management of their oncology program, focusing primarily on their Phase I FIH study which is currently recruiting. The Executive Director will be responsible for: Reporting into the CMO Providing critical leadership, oversight, and line management for early-stage oncology program ensuring that clinical trials are conducted in accordance with the protocols, timelines, and budgets Supporting cross functional development of departmental policies Developing and implementing study and program budgets, including CRO/vendor budgets and contracts with a planning horizon of 1-2 years Management of clinical trials and operations in one or more drug development programs Leading site and vendor selection processes, including, the selection of Contract Research Organizations (CROs) An ideal candidate for this role MUST haveโ€ฆ 15+ years of biopharma INDUSTRY experience REQUIRED 8+ years of CRO trial management experience 3+ years of Associate Director/Director experience at a small biotech Demonstrated success identifying, negotiating and overseeing outsourced vendors A working knowledge of ICH GCP guidelines Benefits: Pre-IPO biotech company Competitive salary with comprehensive benefits (90% medical coverage) Flexible PTO and WFH arrangements 401K contribution Cell phone reimbursement, life insurance, and additional perks If you are interested in this Executive Director of Clinical Operations position, don't hesitate to reach out!

US$265000 - US$300000 per year
San Francisco
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Director/Sr. Director Clinical Operations

Senior Director of Clinical Operations Salary: ($240,000-$260,000) Remote (USA) Job Description This global pharma company is developing treatments in several therapeutic areas, with a focus in oncology. This company has an extensive pipeline, partnered with some of the biggest pharma companies in the world, and are looking for a Sr. Director to lead the Clinical Operations team. Responsibilities Supervise and direct clinical trials, ensuring their timely completion within budget, and adherence to SOPs, FDA/EMA regulations, and ICH/GCP guidelines. Act as the face of Clinical Operations ("ClinOps") in cross-functional study teams, Vendor, and CRO operational meetings, ensuring alignment with worldwide operational protocols. Handle the selection, initiation, management, and supervision of various vendors, including CROs, imaging services, central and specialized labs, eCOA providers, and compliance partners. Responsible for the review and oversight of tasks in study management plans for operations and all operational activities associated with clinical trials. Qualifications Possess over 15 years of experience in Clinical Operations Engaging with CROs and other vendors, and progressively assuming more significant roles. At least 8 years of Oncology (phase 1-3) experience on the sponsor side Familiarity with global (FDA, EMA, APAC) regulations and ICH/GCP guidelines is essential, accompanied by prior involvement in collaborative, cross-functional settings. Benefits Medical, Dental, Vision Insurance 401(k) Competitive salary, bonuses, and equity

US$240000 - US$260000 per year
United States of America
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Director/Senior Director of Clinical Operations

Salary: $220-275K Company Summary: A precision IO biotechnology company is seeking a Director/Senior Director of Clinical Operations to head up their clinical operations team on a hybrid capacity in their SF office. Their mission is to develop best-in-class immunotherapies to address unmet needs within the oncology and their pipeline consists of 1 Phase I asset and 4 more preclinical assets and the Director/Senior Director will be a key leader in the oversight and management of their oncology program, focusing primarily on their Phase I FIH study which is currently recruiting. The Director/Senior Director will be responsible for: Reporting directly into the CMO Providing critical leadership, oversight, and line management for early-stage oncology program ensuring that clinical trials are conducted in accordance with the protocols, timelines, and budgets Supporting cross functional development of departmental policies Developing and implementing study and program budgets, including CRO/vendor budgets and contracts with a planning horizon of 1-2 years Management of clinical trials and operations in one or more drug development programs Leading site and vendor selection processes, including, the selection of Contract Research Organizations (CROs) An ideal candidate for this role MUST haveโ€ฆ 15+ years of biopharma INDUSTRY experience REQUIRED 8+ years of CRO trial management experience 3+ years of Associate Director/Director experience at a small biotech Demonstrated success identifying, negotiating and overseeing outsourced vendors A working knowledge of ICH GCP guidelines Benefits: Pre-IPO biotech company Competitive salary with comprehensive benefits (90% medical coverage) Flexible PTO and WFH arrangements 401K contribution Cell phone reimbursement, life insurance, and additional perks If you are interested in this Director/Senior Director of Clinical Operations position, don't hesitate to reach out!

US$220000 - US$280000 per year
San Francisco
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Clinical Trial Manager

Clinical Trial Manager Salary: ($140,000-$160,000) San Francisco Bay Area This publicly traded pharma/biotech company is at the forefront of drug development. They currently have over 3 assets in the clinic, and several others still in preclinical/drug discovery. This biotech has stayed true to their mission by helping treat patients through their developments in Oncology, specifically solid tumor. The team is currently looking for a CTM to help lead the clinical operations team. Responsibilities: Engage in the process of choosing CROs, advisors, and additional service providers Play a role in management choices regarding resource needs and approach for study teams Oversee that studies are carried out following the protocol, ICH-GCP guidelines, regional regulations, and relevant standard operating procedures (SOPs) Contribute to the creation, upkeep, and refreshment of SOPs for Clinical Operations and Clinical Development Guide less experienced personnel when necessary. An ideal candidate for this role will have: A Bachelor's degree in a life science related field Clinical operations experience required, 4+ years on the sponsor side Strong phase 1-3 oncology (solid tumor) experience Strong oral and written communication skills with ability to work with cross-functional teams This firm greatly values its employees as seen through their competitive compensation packages: 401(k) matching Equity Annual bonus Health/life insurance PTO If you're interested in joining this dynamic team, please apply now!

US$140000 - US$160000 per year
San Francisco
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Clinical Trial Manager

Clinical Trial Manager Philadelphia, PA (Hybrid) $130,000 - $160,000 Job Description A pioneering precision medicine enterprise is actively seeking a Clinical Trial Manager to join its esteemed team. Renowned for leadership in targeted oncology, the company is dedicated to reshaping the landscape of cancer care. Utilizing state-of-the-art technologies, they tailor treatments to meet the unique needs of individual patients. Embracing a collaborative culture, the company fosters innovation, providing an opportunity for professionals to contribute to groundbreaking advancements in precision oncology. This CTM will hold a pivotal role in steering the evolution of healthcare, leaving a lasting impact on the lives of cancer patients. Key Qualifications Proven track record with a significant duration of experience working specifically in the field of Oncology within the pharmaceutical or biotech industry. In-depth knowledge of Oncology clinical trials, including protocol design, patient recruitment, and monitoring, with a demonstrated ability to navigate the unique challenges associated with neurological disorders. Comprehensive understanding of regulatory requirements and guidelines, ensuring compliance with regulatory standards throughout the drug development process. Substantial experience in managing investigational sites, building and maintaining effective relationships, and optimizing site performance to ensure successful trial execution. Proficiency in overseeing data review processes, including source data verification and analysis, to ensure the accuracy and integrity of clinical trial data in the oncology therapeutic area. Roles and Responsibilities Lead and oversee the planning, initiation, and execution of clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. Effectively manage relationships with investigational sites, fostering collaboration, providing support, and addressing site-specific needs to optimize site performance throughout the trial. Implement robust data monitoring processes, conducting regular reviews and source data verification to ensure the accuracy and integrity of data collected in clinical trials. Ensure all aspects of clinical trials comply with relevant regulatory requirements and guidelines, collaborating with regulatory affairs to address any compliance-related issues and facilitate successful trial outcomes. Proactively identify potential risks associated with Oncology trials and develop strategic plans for risk mitigation. Address and resolve issues promptly to ensure the smooth progression of the trial and meet project timelines. Benefits 401(k) with percentage match Medical, Dental, Vision Performance and target based bonuses PTO and Holidays

US$130000 - US$160000 per year
United States of America
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Associate Director Clinical Operations

Salary: $200,000-$230,000 Associate Director Clinical Operations Remote (USA) Job Description Join an innovative biotech company at the forefront of cutting-edge research dedicated to tackling rare diseases. Their unwavering commitment to innovation drives them to the frontlines of scientific discovery, where they focus their energies on an extraordinary mission: combating rare diseases that have long been neglected by traditional pharmaceutical approaches. What sets them apart is their audacious spirit, tireless dedication, and the belief that no challenge is insurmountable. They stand at the intersection of cutting-edge science and compassionate care, working tirelessly to provide hope where it has been scarce and solutions where they have been elusive. As an Associate Director of Clinical Operations, you will be an integral part of our mission-driven team. Responsibilities Identify and proactively address potential risks and issues in clinical trials, implementing mitigation plans to ensure trial success Provide leadership and mentorship to clinical operations teams, fostering a collaborative and high-performance work environment while managing and developing talent within the department Collaborate with cross-functional teams to develop and execute clinical trial strategies aligned with the company's goals and objectives Ensure that all clinical operations comply with regulatory requirements and industry standards, maintaining the highest quality standards in study conduct and documentation Oversee relationships with CRO's, vendors, and external partners, ensuring their performance aligns with project objectives and budgets Qualifications 8+ years of hands-on experience in clinical operations within the biotech or pharmaceutical industry, including direct involvement in planning and managing clinical trials A deep understanding of rare disease clinical trials, including knowledge of the unique challenges and considerations associated with these trials, is highly desirable At least a bachelor's degree in a relevant life sciences field Excellent verbal and written communication skills, including the ability to convey complex scientific and clinical information to both technical and non-technical stakeholders Proficiency in regulatory compliance and an in-depth understanding of international regulations and guidelines related to clinical trial conduct Benefits Medical, dental, vision insurance 401(k) PTO and Holidays

US$200000 - US$230000 per year
United States of America
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Director Clinical Operations

Director, Clinical Operations $215,000-$240,000 Boston, MA (Hybrid) The biotechnology company is at the forefront of groundbreaking research in the field of Immuno-Oncology. They harness the power of the immune system to fight cancer, firmly establishing themselves as pioneers in this rapidly evolving field. Guided by a visionary team of industry veterans and seasoned experts, their leaderships paves the way for unparalleled success and growth within the biotech industry. Their proven track record in oncology speaks for itself. They've developed innovative gene therapies that have shown remarkable efficacy in targeting cancer cells with unprecedented precision, offering new hope to patients and transforming the landscape of cancer care. But their journey doesn't end just there. With their expertise in gene therapy and commitment to scientific innovation, they've poised to extend the reach of our technology to tackle other therapeutic challenges. Leveraging their cutting-edge gene therapy platform io address a broader spectrum of diseases in other therapeutic areas. Position Overview: As the Director of Clinical Operation, you will play a key role in leading and overseeing clinical operations activities for their Immuno-Oncology programs. Based in their Boston office, you will be responsible for driving the successful execution of clinical trials from early-phase trials through phase III. The Director will guide the planning and management of these programs, making sure everything runs smoothly. This is a dynamic leadership position within a cutting-edge biotech company dedicated to revolutionizing different treatments with gene therapy . Responsibilities: Offers strategic leadership, expert guidance, and thorough oversight to ensure the seamless management of all clinical trials. Spearheads the hiring process to onboard top talent crucial for trial success. Designs, implements, and meticulously manages clinical trials within allocated budgets and predetermined timelines. Identifies, evaluates, and selects suitable investigators/sites and service providers in alignment with project needs and company standards. Leads and mentors a dynamic clinical team, fostering individual career growth and monitoring professional advancement. Facilitates cross-departmental collaboration with research and development, regulatory affairs, and medical affairs to drive comprehensive trial strategies and execution. Qualifications: Will only consider candidates with recent experience within a biotech/ pharma company. Requires a minimum of 5 years of experience in senior management roles within the industry. Must hold an advanced agree in relevant scientific discipline. Proficiency in ICH GCP guidelines is essential. Exceptional communication abilities are a must. Adapt quickly to changing priorities and unforeseen challenges, proactively addressing any issues. Extensive experience leading and managing the end-to-end interview process as a hiring manager, ensuring the successful identification and selection of top talent. Demonstrated track record of effectively managing clinical studies within designated program budgets and timelines, including expertise in developing clinical study protocols, regulatory documentation, and SOPs. Minimum of 5 years of experience in Oncology (preferred, but candidates with expertise in other therapeutic areas will also be considered). Note: This is a confidential search. All inquiries and applications will be handled with discretion

US$215000 - US$240000 per year
Boston
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Clinical Trial Manager / Senior Clinical Trial Manager

Salary: $150K -180K Company Summary: A global immunology focused pharmaceutical group with an impressive track record is seeking a Clinical Trial Manager or a Senior Clinical Trial Manager for a hybrid role located in Palo Alto, CA. Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior). Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 6 indications in Phases II and III, so they are looking for a driven, growth-oriented (Senior) Clinical Trial Manager to head up their Phase III studies. The CTM / Senior CTM will be responsible for: Execution and management of Phase 3 clinical studies Managing and coordinating different aspects of clinical monitoring and site management Prepare and approve study documents Coordinate and contribute to the design of study materials Periodic travel (< 20%) An ideal candidate for this role MUST haveโ€ฆ 7+ years of biopharma INDUSTRY experience 5+ years of direct trial management, rare disease / autoimmune / immunology trials PREFERRED A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline A working knowledge of ICH GCP guidelines Benefits: Competitive salary with benefits (100% Medical HMO Coverage) High degree of commercial exposure early in your career Being a part of team whose work directly aims to improve the quality of people's lives Great work-life balance If you are interested in this Clinical Trial Manager / Senior Clinical Trial Manager role, send over a CV!

US$150000 - US$180000 per year
San Francisco
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Clinical Trial Manager

Clinical Trial Manager Boston, MA (Hybrid) $140,000 - $160,000 Job Description Partnering with a cutting-edge Rare Disease company, EPM is engaged in revolutionizing the landscape of Rare Disease care. This forward-thinking organization, currently in the clinical stage, is dedicated to unraveling the complexities of Rare and Ultra Rare Diseases through groundbreaking research and innovative therapies. With a commitment to pioneering first-in-class treatments, they are shaping the future of healthcare. Join us in a pivotal role where you can contribute to strategies and oversight, ensuring these transformative therapies reach individuals in need. Step into the forefront of Rare Disease innovation and make a lasting impact. Key Qualifications Extensive Rare Disease Experience: Proven track record with a significant duration of experience working specifically in the field of Rare Diseases disorders within the pharmaceutical or biotech industry. Clinical Trial Expertise: In-depth knowledge of Rare Disease clinical trials, including protocol design, patient recruitment, and monitoring, with a demonstrated ability to navigate the unique challenges associated with Rare Diseases. Regulatory Knowledge: Comprehensive understanding of regulatory requirements and guidelines related to Rare Disease therapies, ensuring compliance with regulatory standards throughout the drug development process. Site Management Skills: Substantial experience in managing investigational sites for Rare Disease, building and maintaining effective relationships, and optimizing site performance to ensure successful trial execution. Data Quality Assurance: Proficiency in overseeing data review processes specific to Rare Disease trials, including source data verification and analysis, to ensure the accuracy and integrity of clinical trial data in the neurology therapeutic area. Roles and Responsibilities Clinical Trial Oversight: Lead and oversee the planning, initiation, and execution of Rare Disease clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. Site Management and Collaboration: Effectively manage relationships with investigational sites, fostering collaboration, providing support, and addressing site-specific needs to optimize site performance throughout the trial. Data Monitoring and Analysis: Implement robust data monitoring processes, conducting regular reviews and source data verification to ensure the accuracy and integrity of data collected in Rare Disease clinical trials. Regulatory Compliance: Ensure all aspects of Rare Disease clinical trials comply with relevant regulatory requirements and guidelines, collaborating with regulatory affairs to address any compliance-related issues and facilitate successful trial outcomes. Risk Management and Issue Resolution: Proactively identify potential risks associated with trials and develop strategic plans for risk mitigation. Address and resolve issues promptly to ensure the smooth progression of the trial and meet project timelines. Benefits: Medical Insurance PTO 401(k)

ยฃ140000 - ยฃ160000 per year
United States of America
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