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

Clinical Trial Manager

Clinical Trial Manger (Hybrid in Manhattan, NY) Salary: $130,000-$160,000 This company is a fast growing biotechnology company that specializing in bringing innovative and enhanced versions of successful CNS treatments to the US market. Their approach is to create a research-focused organization dedicated to generating novel intellectual property related to improved versions of these previously successful CNS drugs. Position Overview : The company is looking for a Clinical Trial Manager who will play a pivotal role in driving and managing their ongoing clinical trial Phase 2 programs forward and ensuring the success of it. This candidate will report directly into the Senior Director of Clinical Operations . Responsibilities: Collaborate with our clinical operations team to oversee our ongoing Phase 2 clinical trial in schizophrenia. Shared responsibility for monitoring overall study integrity, interpreting accumulating data on the molecule's safety and efficacy, and ensuring compliance with regulatory requirements in global drug development. Interact with our CRO, Clinical Trial Manager, and Project Manager, serving as the lead contact with Phase 2 sites to manage enrollment effectively. Play a key role in maintaining adherence to Good Clinical Practices, pharmacovigilance standards, and all other quality standards throughout the research process. Actively participate in weekly CRO/Internal team communications, contributing to progress reports and discussions on project risks and strategies Maintain a relationship with CRO Executive Team and other vendors as needed. Experience: Must have a Bachelor's Degree; an advanced degree in a scientific field is considered advantageous. Must have at least 3 years' experience in managing clinical operations, specific in CNS indications. Experience in schizophrenia clinical trial is a nice to have. Knowledge of GCPs, ICH guidelines and FDA regulations Solid understanding of clinical indications and the drug development process. Must be able to go on site at least 3 days a week in Manhattan, NY. Up to 25% travel to 24 sites around the US. Benefits: Competitive salary Liquid stock options package. Notable leadership and growth opportunities.

US$130000 - US$160000 per year
Manhattan
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Head of Clinical Operations

Head of Clinical Operations Salary: ($265,000-$340,000) Remote This clinical-stage biotech is developing revolutionary treatments in the ophthalmology & gene therapy space . This company's pipeline has some very promising assets that will offer great exposure to early phase advancements. The executive team is looking to hire a Head of Clinical Operations as the first hire on the Clin Ops team. This full-time employee will be working with and reporting into the executive team. Responsibilities: Tasked with the selection and oversight of CROs and vendors Responsible for overall Clinical Operations strategy and budgeting Providing both operational and strategic input into training materials, program-specific standards, clinical development plans, and the clinical sections of regulatory documentation. An ideal candidate for this role will have: BA/BS in life science related field Experience managing global ophthalmology and/or gene therapy trials 7+ years of Clinical Operations experience on the sponsor side Strong understanding of ICH GCP guidelines and FDA/EMEA regulation Experience managing direct reports This firm greatly values its employees as seen through their competitive compensation packages: Pre-IPO equity Annual bonus Health insurance Unlimited PTO If you're interested in joining this dynamic team, please apply now!

US$265000 - US$340000 per year
San Francisco
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Senior Clinical Data Manager

We're currently working with an established Biotech company that is looking to add a Senior Clinical Data Manager to expand their growing team and small company team environment. They're currently looking for someone with previous Senior Clinical Data Management experience working with prior early phase/phase II clinical trial experience. Prior history working with Inflammatory Disease and Immuno-Oncology would be a bonus. This Sr Clinical Data Manager position will: Represent Data Management at Study Team Meetings Lead the development of data edit checks specification and data listings Provide input of data-sets, validation plan specification, as well as performing data submission review. Develop or lead the development of the Data Management Plan for a clinical study. Perform reconciliation of data from external data sources against the clinical database Perform quick hypothesis generation and perform UAT testing The Sr Clinical Data Manager should have: 8+ years experience in Clinical Data Management clinical trials in a Biotech/Pharma environment. Experienced working with Various EDC's (Medidata Rave, Oracle, Inform) Experience with Clinical development/trial conduct, including ICH-GCP Inflammatory Disease and Immun-Oncology experience (A Bonus) CRO Oversight/Vendor Management experience Experienced working in Study Start-up through Close-Out Benefits/perks: Remote Opportunity Benefits; (Health, Dental, Vision) W2 Only, No C2C

US$75 - US$95 per hour
San Francisco
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Director, Clinical Operations

Salary: 215K-250K Company Summary: A cutting edge biotech company with an innovative pipeline is seeking a motivated Director of Clinical Operations for a hybrid role in the San Francisco Bay Area. Since their first clinical trial in 2012, they've gotten 2 approvals which generated $50 milliuon this past year in revenue. Currently, they have 8 indications in Phases II and III, so they are looking for a driven, growth-oriented Director to facilitate their immunology programs on a global scale. The Director will be responsible for: Heading up the Immunology Clinical Operations team Managing and establishing clinical programs in accordance with the Executive Management Team Directing and executing clinical programs in accordance with established timelines Study feasibility assessments, document management, pharmacovigilance, and ethics committee documentation Being involved with the hiring process An ideal candidate for this role MUST have… Bachelor's in biomedical science or medical related field 6 years of experience with immunology or immunotherapy trials 5 years of experience in a senior management level role At least 3 years of sponsor and/or biotech experience in a mangerial position Working knowledge of ICH GCP guidelines Benefits: Competitive salary with benefits and stock options Work life balance Unlimited PTO Getting to be apart of a team and company that aims to improve the lives of patients through revolutionary advancements in immunotherapy If you're interested in this role, send an application our way!

US$215000 - US$250000 per year
San Francisco
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Sr. Clinical Trial Manager / AD, Clinical Operations

Salary: $160-195K Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Senior Clinical Trial Manager or Associate Director of Clinical Operations for a hybrid role. Their commercial supply of pharmaceutical products has generated upwards of $80 million in Q2 sales. Since their first clinical trial in 2002, they've had 3 approvals already on the market. Currently, they have 8 indications in Phases II and III, so they are looking for a driven, growth-oriented Senior CTM or AD to facilitate their clinical programs on a global scale. The SCTM/AD will be responsible for: Managing and establishing clinical trials in accordance with the Executive Management Team Directing and executing clinical trials in accordance with established timelines Study feasibility assessments, document management, pharmacovigilance, and ethics committee documentation Reporting into the Director An ideal candidate for this role MUST have… Bachelor's in biomedical science or medical related field 5+ years of experience in a trial/study/project management level role 5+ years at a biotech or pharma - MUST HAVE SPONSOR EXPERIENCE Previous experience with immunology trials (Phase I-IV) Working knowledge of ICH GCP guidelines Benefits: * Competitive salary with benefits * Being a part of team whose work directly aims to improve the quality of people's lives * Great work-life balance If you're interested in this role, send an application our way!

US$160000 - US$200000 per year
United States of America
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SR Clinical Trial Associate - BAY AREA HYBRID

My client is a small but rapidly growing and in order to support their growth are looking to add a talented CTA to their team. Responsibilities will include but are not limited to: Management of all clinical documents TMF oversight and reconciliation Management and maintenance of TMF Support cross-functional study teams by ensuring timely and effective project tracking and administrative support of clinical research studies Support clinical study managers and directors of clinical operations where needed Coordinate team and investigator meeting, take meeting minutes as needed Updating milestones on clinicaltrials.gov Coordinate the ordering and delivery of needed supplies such as lab supplies, drug supplies, etc. as needed Contribute to development of SOPs Participation in regular internal quality auditing of clinical study documents Qualifications include: BA or BS in a life sciences field or healthcare, or a BSN 3+ years clinical research experience Knowledge of ICH GCP regulations, SOPS and internal tracking systems Effective interpersonal and communication skills Flexibility and adaptability within a highly dynamic clinical environment Ability to work independently as well as part of a team Ability to build and maintain successful professional relationships with vendors, other staff and investigators Experience with TMF maintenance and management Organization skills, with a detail-oriented nature

US$40 - US$55 per hour + Healthcare, 401k
San Francisco
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Director Clinical Operations

$220,000 - $250,000 Director Clinical Operations Remote (USA) Job Description Come join one of the most innovative biotech's in the industry as a fully remote Director of Clinical Operations. Focusing on precision medicine which targets difficult to treat proteins that cause the reproduction of cancer cells, this client is shaping the way treatments can not only be more cost effective for patients, but also more efficient and effective. Be on the right side of history by joining a collaborative and cross functional team that will help shape the way cancer treatments are developed and distributed to patient populations. Responsibilities Develop and implement strategic plans for clinical trials in alignment with the company's overall objectives and regulatory requirements. Ensure the effective management of CROs (Contract Research Organizations), vendors, and other external partners involved in clinical trial activities. Establish and maintain high-quality standards for clinical trial conduct in accordance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and internal standard operating procedures. Foster effective communication and collaboration among internal teams and external stakeholders, including investigators, site personnel, and regulatory authorities. Represent the company in interactions with regulatory agencies, ensuring clear and timely communication of clinical trial progress and results. Key Qualifications Proven track record of successful leadership in clinical operations, preferably in the biotech or pharmaceutical industry. Strong understanding of clinical research methodologies, regulations, and compliance standards. Strong leadership skills with the ability to build and lead cross-functional teams effectively. Demonstrated experience in recruiting, developing, and managing high-performing clinical operations teams. Ability to speak Mandarin highly valued Benefits Competitive compensation 401(k), Medical, Dental, Vision Performance based bonuses and incentives

US$220000 - US$250000 per year
United States of America
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Associate Director Clinical Operations

Salary: $200,000-$230,000 Associate Director Clinical Operations San Francisco, CA (Hybrid) Job Description Embark on a transformative career with our innovative biotech venture nestled in the heart of San Francisco, where innovation meets impact in the realm of oncology. We are on a relentless pursuit of redefining cancer treatment through the precision of personalized medicine. As we chart new territories in therapeutic breakthroughs, we're actively seeking an exceptional Associate Director of Clinical Operations to be a driving force in our revolutionary projects. Picture yourself at the forefront of a company that's unraveling the mysteries of cancer by targeting notoriously resilient protein cells. With a commitment to precision medicine, we're unlocking pathways to treat the toughest cases with unprecedented accuracy. Your role will be instrumental in orchestrating clinical trials that not only push the boundaries of science but redefine the future of cancer care. Join us in our mission to make history, where every step forward is a step closer to conquering cancer. If you're passionate about pioneering solutions and eager to leave an indelible mark on the world of oncology, seize this opportunity to be part of a company where innovation thrives, and challenges are met with unwavering determination. Responsibilities Clinical Trial Oversight: Lead and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements, while maintaining the highest standards of data quality and patient safety. Cross-Functional Collaboration: Foster seamless collaboration between diverse teams, including clinical development, regulatory affairs, data management, and medical affairs, to ensure effective communication and coordination throughout all stages of clinical operations. Strategic Planning: Contribute to the development and execution of strategic plans for clinical programs, providing valuable insights and recommendations to enhance trial design, patient recruitment strategies, and overall project success. Risk Management: Identify potential risks and challenges in clinical trial operations, developing proactive mitigation strategies to address issues promptly, ensuring the smooth progress of trials and the achievement of key milestones. Vendor Management: Collaborate with external vendors, including clinical research organizations (CROs) and other service providers, to optimize resources, budgets, and timelines, while maintaining strong partnerships to achieve project goals. Regulatory Compliance: Stay abreast of evolving regulations and guidelines, ensuring that all clinical operations activities adhere to ethical, legal, and regulatory standards, and contribute to the preparation of regulatory submissions as needed. Continuous Improvement: Drive a culture of continuous improvement by assessing and implementing innovative approaches and technologies in clinical trial operations, striving for increased efficiency, data quality, and overall excellence in oncology research. Key Qualifications Clinical Operations Expertise: A minimum of 8-10 years of hands-on experience in clinical operations within the biotech or pharmaceutical industry, demonstrating a comprehensive understanding of the end-to-end clinical trial process. Oncology Background: Strong background in oncology clinical trials, with a focus on precision medicine and a deep understanding of the challenges and nuances associated with targeting specific protein cells in cancer treatment. Leadership and Team Management: Proven ability to lead and inspire cross-functional teams, with a track record of successfully managing and mentoring clinical operations professionals. Demonstrated leadership in driving teams towards shared goals and objectives. Regulatory Compliance: In-depth knowledge of global regulatory requirements for clinical trials, with the ability to navigate and ensure compliance with regulatory standards. Experience in contributing to regulatory submissions and interactions with health authorities is highly desirable. Strategic Thinking: Strong strategic mindset with the ability to contribute to the development and execution of clinical development plans. Proven experience in providing strategic input to enhance trial design, patient recruitment, and overall clinical program success. Benefits Competitive Compensation Medical, Dental, Vision Insurance 401(k)

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

Salary: 215K-250K Company Summary: A cutting edge biotech company with an innovative pipeline is seeking a motivated Director of Clinical Operations for a hybrid role in the San Francisco Bay Area. Since their first clinical trial in 2012, they've gotten 2 approvals which generated $50 milliuon this past year in revenue. Currently, they have 8 indications in Phases II and III, so they are looking for a driven, growth-oriented Director to facilitate their immunology programs on a global scale. The Director will be responsible for: Heading up the Immunology Clinical Operations team Managing and establishing clinical programs in accordance with the Executive Management Team Directing and executing clinical programs in accordance with established timelines Study feasibility assessments, document management, pharmacovigilance, and ethics committee documentation Being involved with the hiring process An ideal candidate for this role MUST have… Bachelor's in biomedical science or medical related field 6 years of experience with immunology or immunotherapy trials 5 years of experience in a senior management level role At least 3 years of sponsor and/or biotech experience in a mangerial position Working knowledge of ICH GCP guidelines Benefits: Competitive salary with benefits and stock options Work life balance Unlimited PTO Getting to be apart of a team and company that aims to improve the lives of patients through revolutionary advancements in immunotherapy If you're interested in this role, send an application our way!

US$215000 - US$250000 per year
San Francisco
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Experienced Clinical Research Associate

We are looking for an experienced Clinical Research Associate to join our client's team in Korea. The client is a biopharmaceutical company that focuses on developing and manufacturing innovative therapies for patients worldwide. As a Clinical Research Associate, you will work closely with the clinical team to ensure that clinical trials are conducted according to the protocols and regulatory requirements. Responsibilities As a Clinical Research Associate, your main responsibilities will include: - Conducting site visits to ensure that the clinical trials are conducted according to the protocols and regulatory requirements - Monitoring the progress of the clinical trials and ensuring that they are completed within the timelines and budget - Ensuring that the trial data is accurate, complete, and verifiable by source documentation - Coordinating with the clinical team and investigators to ensure that the trials are conducted in compliance with the protocol and regulatory requirements - Identifying and resolving issues related to the conduct of the clinical trials - Maintaining study files and ensuring that they are up-to-date and accurate Skills To be considered for this role, you should have the following skills: - Strong knowledge of clinical research and regulatory requirements - At least 5 years of experience as a CRA, experience in Oncology studies preferred - Excellent communication and interpersonal skills - Strong attention to detail and ability to work independently - Good problem-solving skills and ability to think critically - Ability to work in a team environment and build strong relationships with stakeholders - Good organizational and time management skills How to Apply If you are interested in this position, please submit your CV to for consideration.

Negotiable
South Korea
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Clinical Trial Manager

$130,000-$160,000/year Clinical Trial Manager San Francisco, CA (Hybrid) Job Description A cutting-edge pharmaceutical oncology company is seeking a highly motivated and detail-oriented Clinical Trial Manager to help revolutionize cancer treatment. In this role, you will play a crucial part in the planning, execution, and management of clinical trials, ensuring the successful development of life-changing medical products. As a Clinical Trial Manager, you'll have the chance to work on pioneering clinical trials that are at the forefront of scientific advancements. Their groundbreaking research harnesses AI-driven drug discovery, precision medicine, and immunotherapies to target cancer cells with unprecedented accuracy. You'll be an essential part of the mission, leading and guiding cross-functional teams towards the successful execution of groundbreaking clinical trials. Responsibilities: Lead the planning, initiation, and execution of clinical trials in accordance with approved protocols, GCP guidelines, and regulatory requirements. Collaborate with key stakeholders, including Clinical Operations, Data Management, Regulatory Affairs, and Investigator Sites, to ensure seamless coordination and effective trial implementation. Develop and manage trial budgets, resource allocation, and timelines to achieve study objectives within specified timelines. Oversee the selection and qualification of investigative sites, as well as training of site personnel on study protocols and procedures. Conduct regular site monitoring visits and provide guidance to ensure adherence to study protocols, data integrity, and participant safety. Facilitate communication and maintain a strong relationship with study investigators, sponsors, and CRO partners. Ensure timely and accurate reporting of trial progress to internal and external stakeholders Qualifications: Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree is a plus. Proven experience (minimum 5 years) as a Clinical Trial Manager within the pharmaceutical or biotechnology industry. Comprehensive understanding of clinical trial regulations, GCP guidelines, and industry best practices. Strong project management skills with a track record of successfully managing complex clinical trials. Excellent leadership, communication, and negotiation skills with the ability to build and maintain effective working relationships. Proficient in problem-solving and decision-making, capable of resolving challenges and making data-driven decisions. Experience working with CROs and managing outsourced clinical trial activities. Benefits: Medical Insurance PTO 401(k)

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

Salary: $215-$250K - Director Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Director of Clinical Operations for a remote role. Their commercial supply of pharmaceutical products has generated upwards of $80 million in Q2 sales. Since their first clinical trial in 2002, they've had 3 approvals already on the market. Currently, they have 12 indications in Phases II and III, so they are looking for a driven, growth-oriented Director to facilitate their clinical programs on a global scale. The Director will be responsible for: * Managing and establishing clinical programs in accordance with the Executive Management Team * Directing and executing clinical programs in accordance with established timelines * Study feasibility assessments, document management, pharmacovigilance, and ethics committee documentation An ideal candidate for this role MUST have… Bachelor's in biomedical science or medical related field 5+ years of experience in a senior management level role 5+ years at a biotech or pharma Previous experience with immunology trials (Phase I-IV) Working knowledge of ICH GCP guidelines Benefits: * Competitive salary with benefits * Being a part of team whose work directly aims to improve the quality of people's lives * Great work-life balance If you're interested in this role, send an application our way!

US$215000 - US$215001 per year
San Francisco
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