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 – 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 – a market that is expected to reach €9.6bn by 2025, registering a CAGR of 12.8% during this period.


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Clinical Operations Jobs

Associate Director / Director, Clinical Operations

Salary: $185K-210K Company Summary: A global immunology focused pharmaceutical group with an impressive track record is seeking an Associate Director of Clinical Operations 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 Associate Director will be responsible for: Managing CTMs to ensure timely execution of Phase 3 studies Supervising study programs as well as participating in the preparation of study budgets and contract negotiations Contributing to cross functional development of departmental policies Overseeing vendors in conjunction with study managers Periodic travel (< 20%) An ideal candidate for this role MUST have… 7+ years of biopharma INDUSTRY experience 6+ years of senior management experience - rare disease / autoimmune / immunology therapeutic experience greatly 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 Associate Director/Director role, don't hesitate to reach out!

US$185000 - US$210000 per year
San Francisco
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Associate Director / Director, Clinical Operations

Salary: $185K-210K Company Summary: A global immunology focused pharmaceutical group with an impressive track record is seeking an Associate Director of Clinical Operations 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 Associate Director will be responsible for: Managing CTMs to ensure timely execution of Phase 3 studies Supervising study programs as well as participating in the preparation of study budgets and contract negotiations Contributing to cross functional development of departmental policies Overseeing vendors in conjunction with study managers Periodic travel (< 20%) An ideal candidate for this role MUST have… 7+ years of biopharma INDUSTRY experience 6+ years of senior management experience - rare disease / autoimmune / immunology therapeutic experience greatly 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 Associate Director/Director role, don't hesitate to reach out!

US$185000 - US$210000 per year
San Francisco
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Clinical Trial Manager / Sr. Clinical Trial Manager

Salary: $140-190K Company Summary: Working with a clinical-stage biotech company that's looking for a Clinical Trial Manager or Sr. Clinical Trial Manager to come into their South SF office on a hybrid/full-time basis. Their mission is to create a best-in-class immunotherapies that address unmet needs within oncology and their pipeline consists of 2 Phase II assets, 1 Phase I asset and 6 more preclinical assets. The CTM/SCTM will play a pivotal role in the oversight and management of their oncology studies. The CTM/Sr. CTM will be responsible for: * Reporting directly into the Director, Clinicial Operations * Managing Phase 2 global oncology trials ensuring they are conducted in accordance with protocols, timelines, and budgets * Assisting in the management of key study-related activities and deliverables * Coordinating and contributing to the design of study materials and protocols * Conducting (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with CRO An ideal candidate for this role MUST have… * 5+ years of biopharma INDUSTRY experience REQUIRED * 3 years of trial management experience REQUIRED * A working knowledge of ICH GCP guidelines * An undergraduate degree in a relevant field of study Benefits: * Pre-IPO biotech company with good runway * Competitive salary with comprehensive benefits (85% medical coverage) * Flexible PTO arrangements * 401K contribution If you are interested in this CTM/SCTM position, don't hesitate to reach out!

US$140000 - US$190000 per year
San Francisco
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Clinical Trial Manager / Sr. Clinical Trial Manager

Salary: $140-190K Company Summary: Working with a clinical-stage biotech company that's looking for a Clinical Trial Manager or Sr. Clinical Trial Manager to come into their South SF office on a hybrid/full-time basis. Their mission is to create a best-in-class immunotherapies that address unmet needs within oncology and their pipeline consists of 2 Phase II assets, 1 Phase I asset and 6 more preclinical assets. The CTM/SCTM will play a pivotal role in the oversight and management of their oncology studies. The CTM/Sr. CTM will be responsible for: * Reporting directly into the Director, Clinicial Operations * Managing Phase 2 global oncology trials ensuring they are conducted in accordance with protocols, timelines, and budgets * Assisting in the management of key study-related activities and deliverables * Coordinating and contributing to the design of study materials and protocols * Conducting (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with CRO An ideal candidate for this role MUST have… * 5+ years of biopharma INDUSTRY experience REQUIRED * 3 years of trial management experience REQUIRED * A working knowledge of ICH GCP guidelines * An undergraduate degree in a relevant field of study Benefits: * Pre-IPO biotech company with good runway * Competitive salary with comprehensive benefits (85% medical coverage) * Flexible PTO arrangements * 401K contribution If you are interested in this CTM/SCTM position, don't hesitate to reach out!

US$140000 - US$190000 per year
San Francisco
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Senior Clinical Trial Project Manager

Title: Senior Clinical Trial Project Manager in Los Angeles Introductory Paragraph: Our client, a small medical devices and diagnostics Contract Research Organization (CRO), is seeking an experienced Senior Clinical Trial Project Manager to join their team. The ideal candidate will be responsible for overseeing clinical trials from start-up through close-out phases while ensuring compliance with regulatory standards. Qualifications: - Bachelor's degree or higher in life sciences, healthcare administration, or related field - 1-2 years minimum of experience as a Clinical Project or Trial Manager within the Diagnostic or Medical Device industry - Proven ability to manage multiple studies simultaneously and meet timelines - Strong knowledge of GCP/ICH guidelines & FDA regulations Skills: Project Management - Experience managing all aspects of projects including budgeting & forecasting; demonstrated success leading teams under tight deadlines. Communication Skills - Excellent verbal/written communication skills across different departments/vendors/stakeholders etc; Leadership qualities - Ability to lead cross-functional study teams effectively by establishing clear objectives/deliverables/goals. Attention-to-Detail - A keen eye for detail when reviewing protocols/reports/data-management plans etc. Additional Details: The successful candidate must have prior experience working on CRO side preferably at Small/Mid-size firms and experience in Diagnostics or Medical Devices. This position offers competitive base salary ranging from $100,000-145,000 Apply today if interested!

US$100000 - US$145000 per annum
California
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Clinical Trial Manager/Senior Manager

Location: Seoul, Korea Therapeutic Areas: Oncology, Cardiovascular, Infectious Disease, CNS/Neuroscience An award-winning global Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Clinical Trial Manager to be based in Taiwan. This opportunity provides amazing growth potential, career progression and the chance to be working with a growing company. Responsibilities: Lead projects for multi-service global clinical trials Manage project timelines and deliverables Lead cross functional teams - clinical monitoring, study start-up, regulatory, contract, safety, medical monitoring. Secure new businesses Requirements: Bachelor's degree (Masters or PhD preferred) Relevant experience in clinical trial management in Asia, in a CRO is preferred Preferably a tertiary education in law and/or experience within the Chinese legal jurisdiction Good communication skills and team spirit If you are interested, please apply with your CV attached.

Negotiable
Seoul
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Clinical Study Lead

Our client, a leading biotech company based in Japan is seeking to hire someone with expertise in this field. As the Clinical Study Lead, you will be responsible for overseeing and managing all aspects of clinical studies related to their products. Responsibilities: Plan and execute various phases of clinical trials Ensure compliance with regulatory requirements Manage budgets, timelines and resource allocation Collaborate with cross-functional teams including medical affairs, research & development etc. Qualifications: To qualify as our ideal candidate you should possess; Relevant academic qualifications e.g Medical Device or Healthcare-related degree programs Demonstrated experience having managed multiple global/ regional phase II/III clinical trial projects within Oncology therapeutic area(s). Strong communication skills both verbal and written; fluency in English required; Japanese language proficiency preferred but not mandatory. If you are interested, please apply with your CV attached

Negotiable
Tokyo
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Associate Director Clinical GCP Quality

Our client is an industry-leading biotechnology company that specializes in developing groundbreaking cancer therapies that harness the power of cutting-edge technologies. They are currently seeking a highly experienced professional to join their team as the Associate Director of Clinical (GCP) Quality. Responsibilities: Proven track record in effectively managing and supervising CAPA plans, including writing, reviewing, approving, and closing them. Demonstrated capability in conducting and overseeing site, internal GCP, and vendor audits, along with directing and guiding audit follow-up actions. Proficiency in establishing Quality and Cross-Functional Standard Operating Procedures (SOPs) and processes, along with implementing associated document controls. Experience serving as a global document management system administrator. Skilled in managing and mentoring direct reports. Ability to coordinate cross-functional meetings between departments and Quality teams. Willingness to undertake other duties as assigned. Qualifications: Bachelor's degree or higher qualification within life sciences At least 10 years' experience working in GCP Quality Assurance and/or GCP Compliance, additional GCP Auditing experience preferred In-depth knowledge of global regulations related to good clinical practice Excellent interpersonal communication skills along with proficiency communicating both verbally and written formats. Bilingual Willingness to travel If you are interested, please apply with your CV attached.

Negotiable
Tokyo
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Senior Manager Biostatistics

Client: Clinical-Stage Biotech - Publicly Traded Hiring: Senior Manager, Biostatistics (Third most senior in the company) My client is a cutting-edge clinical-stage biopharmaceutical company on their quest for groundbreaking advancements - The only one to get to commercialization! They are looking to bring on a dynamic Senior Manager, Biostatistics to become the 3rd most senior member within the company. You will have the opportunity to really advance your career, by working closely with the Head of the department and Associate Director on submissions and commercialization of an innovate product. You'll be at the forefront of innovation, working on data analysis of studies linked to a rare technology which is booming at he moment. You will work hand-in-hand with their brilliant statisticians, programmers and clinical teams to craft top-notch deliverables that redefine industry standards. Are you ready to unleash your creativity, collaborate with the best, and drive transformative change? If you're a proactive, visionary thinker who thrives on challenges, then this is the opportunity you've been waiting for! Apply now and be part of a team that's shaping the future of healthcare! Responsibilities: Work closely with CROs on the oversight of statistical and programming deliverables Provide ideas in evaluating innovative methods of study design and analysis Collaborate with other teams - Clinical, Programming and Data Management, to ensure data collection and reporting is correct and appropriate Support on the entire drug development on biostatistical input - study and program design, writing of protocols, CSR, Regulatory documents, SAP, Scientific publications Qualifications 2-3+ years' experience in either research or industry, post PhD PhD in either Biostatistics or Statistics Ability to work onsite in California Please note, to apply for this position you must have rights to work in the USA or a Canadian citizen looking to make the move to California. Reach out to find out more!

Negotiable
California City
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CTM/Sr. CTM

Clinical Trial Manager / Sr. Clinical Trial Manager Salary: ($125,000-$150,000) South San Francisco, CA - Hybrid (3 days per week on-site) This oncology-focused biotech company is located in South SF and is at the forefront of drug development within their specific therapeutic area. Due to being one of the most cutting-edge leaders in this space, the company recently raised over $100M in their latest round of funding. They are currently looking for a CTM / Sr. CTM to join the team and help lead the trial. Responsibilities: Engage in CRO selection and oversight Help lead trials through enrollment, data reviews/collection, etc. Help run investigator meetings Develop study plans, etc. The ideal candidate for this role will have: 5+ years working oncology trials on the sponsor side Phase 1 (FIH and Dose Escalation) Strong ability to communicate and work cross functionally MUST be able to come on-site at least 3 days per week If you're interested in this role, please apply now!

US$125000 - US$150000 per year
South San Francisco
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Clinical Trial Manager

Clinical Trial Manager Boston, MA (Hybrid) $130,000 - $150,000 Job Description EPM is partnered with a cutting-edge biotech that is dedicated to pioneering breakthrough therapies for diverse and traditionally unmet medical needs related to liver diseases. Their mission? To revolutionize healthcare and the way that patients are treated across the globe. With a diverse pipeline of various clinical stage assets across a number of therapeutic areas, the potential regarding their drug platform is unlimited. By harnessing the power of data driven drug development, they are able to precisely and efficiently create new treatments that are not only cheaper, but more effective as well. Key Qualifications Bachelor's degree in a life science related field 5-7 years of managing clinical trials at a Biotech or Pharmaceutical company (not CRO) Experience working on GI, Liver Diseases, Hepatology, or Oncology strongly desired Must be able to come onsite in the greater Boston area Excellent verbal and written communication skills, with the ability to effetively communicate with internal teams, external stakeholders, and study sites. Strong understanding of regulatory requirements governing clinical trials, including FDA regulations, ICH-GCP guidelines, and other relevant standards Roles and Responsibilities Lead and motivate cross-functional teams, including clinical research associates, data managers, and other stakeholders, to ensure effective collaboration and achievement of study goals Identify and mitigate risks throughout the trial lifecycle, proactively addressing issues that may impact study timelines, quality, or compliance. Oversee the development of Clinical Trial protocols, ensuring they adhere to regulatory standards and meet scientific objectives Coordinate all aspects of clinical trial operations, including timelines, budgets, and resources allocation Oversee site selection, initiation, and ongoing monitoring activities to ensure sites are conducting trials according to protocol and in compliance with GCP standards Benefits Medical Dental 401(k) PTO

US$130000 - US$150000 per year
United States of America
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Clinical Trial Manager

Clinical Trial Manger (Hybrid in Boston, MA) Salary: $150,000-$165,000 This company is a fast- growing biotechnology company in Boston, MA dedicated to advancing research, development, and treatments for rare diseases. They are driven by a commitment to innovation and excellence in developing transformative therapies that have the potential to significantly improve the lives of patients and their families. Position Overview : The company is looking for a Clinical Trial Manager you will play a pivotal role in the execution of our clinical development programs aimed at advancing novel therapies for rare diseases. Working closely with cross-functional teams, you will oversee the planning, implementation, and management of clinical trials at various stages of development, ensuring compliance with regulatory standards, protocols, and timelines. Responsibilities: Facilitating effective communication and collaboration across internal and external stakeholders, including clinical investigators, study coordinators, regulatory authorities, and medical monitors. Ensuring adherence to Good Clinical Practice (GCP) guidelines, regulatory requirements, and company SOPs throughout the conduct of clinical trials, maintaining the highest standards of data integrity and patient safety. Identifying potential risks and developing mitigation strategies to ensure the successful execution of clinical trials, proactively addressing issues as they arise. Coordinating all aspects of trial conduct, including budget management, site monitoring, patient recruitment and enrollment, drug supply management, and data collection. Leading the operational planning and initiation of clinical trials, including site selection, investigator meetings, regulatory submissions, and ethics committee approvals. Experience: Bachelor's degree in life sciences, pharmacy, nursing, or related field (advanced degree preferred). Minimum of 3 years of experience in clinical trial management within the pharmaceutical or biotechnology industry, preferably with expertise in rare diseases. Strong understanding of clinical trial design, conduct, and regulatory requirements (FDA, EMA, ICH). Excellent project management skills, with the ability to prioritize tasks, manage competing priorities, and meet deadlines. Effective communication and interpersonal skills, with the ability to build relationships and influence stakeholders at all levels. Proven leadership abilities, with a track record of successfully leading cross-functional teams in a matrix organization. Benefits: Competitive pay (salary, bonus and stock options) Paid time off (PTO) Comprehensive medical coverage (PPO, dental, vision) Notable leadership and growth opportunities. Note: This is a confidential search. All inquiries and applications will be handled with discretion.

US$150000 - US$165000 per year
Boston
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