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

Senior Clinical Trial Technology Imaging Manager

Location Alameda SalaryUS$140000 - US$200000 per year Discipline Clinical Operations ReferencePR/527405_1738019511 Sr. Manager Imaging [Clinical Trial Technology] Salary: ($140,000-$200,000) San Francisco, CA or Philadelphia, PA (on-site 5 days per week) This publicly traded biotech is at the forefront of drug development within oncology. They are revenue generating, as this biotech already has a blockbuster oncology drug approved on the market. They are seeking a Senior Manager Clinical Trial Technology specifically for imaging. Responsibilities: Spearhead the creation and documentation of business and system requirements at the study level in collaboration with internal stakeholders and technology vendors Lead the governance and oversight of IxRS, Imaging, ECG, eCOA, and other Clinical Technology suppliers. Work cross functionally with Clin Ops, Data Management, Biometrics, Clinical Supply, etc.) The ideal candidate for this role will have: BA/BS in a life science related field 8+ years experience within imaging Ability to answer site clinical technical questions Ability to examine and understand the image The company offers a competitive compensation package: Annual bonus Equity package 401(k) match program Insurance (health/vision/dental) If you're interested in this role, please apply now!

US$141500 - US$201000 per year
Alameda
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Head of Clinical / CMO

VP Clinical Affairs Salary: ($200,000 - $300,000) Remote USA This pre-IPO medical device company has developed and manufactured a novel device to treat Mitral Valve Disease. Now, they are currently in the midst of shifting their focus to develop a device for Tricuspid Valve Disease as well. This is an exciting Head of Clinical Affairs opportunity, leading the clinical efforts from the left side of the heart to right. Responsibilities: Lead Clinical Affairs for Mitral + Triscuspid device Develop and implement clinical strategies to support the regulatory approval and commercialization of our medical devices. Oversee the design, execution, and management of clinical trials The ideal candidate for this role will have: 10+ years leading Clinical Affairs teams 10+ years in Structural Heart (mitral + tricuspid) If you're interested, please apply now!

US$200000 - US$300000 per year
United States of America
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Freelance CRA (m.w.d)

We have a current opportunity for a Freelance CRA in Belgium on a contract basis. This is a remote role with some site monitoring visits. Candidates located near Leuven are strongly encouraged to apply.

Negotiable
Belgium
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Associate Director, Clinical Operations

Job Type: Full-time Salary: $190K - $210K Location: San Francisco Bay Area (Hybrid, no relocation at this time) Company Summary: Clinical stage biotech developing a pipeline of best in class cell therapies to treat cancer and autoimmune disease. With an office in SSF, they are hiring an Associate Director, Clinical Operations to join them on a hybrid (2x a week in office) basis. The Opportunity: The AD, Clin Ops will play a critical role in leading the clinical trial team and ultimately, advancing their Ph. 3 cell therapy programs. Reporting to the VP/Head of Clin Ops, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies in a timely manner. Responsibilities: Reporting into the Head of Clin Ops Managing Ph. 3 trials within their oncology program ensuring that clinical trials are conducted in accordance with the protocols, timelines, and budgets Supporting cross functional development of departmental policies Implementing study protocols 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 8+ years of biopharma INDUSTRY experience REQUIRED 5+ years of trial management experience at a small biotech (must be drug development) Demonstrated success identifying, negotiating and overseeing outsourced vendors Familiar with insourced clinical trial model A working knowledge of ICH GCP guidelines Benefits: Pre-IPO biotech company Competitive salary with comprehensive benefits (inc. LTI & STI) Flexible PTO and WFH arrangements 401K contribution Cell phone reimbursement, life insurance, and additional perks

US$190000 - US$210000 per year
San Francisco
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Senior/Executive Director, Clinical Operations

Job Type: Full-time Salary: $275K - $325K Location: San Francisco Bay Area Company Summary: Clinical stage biotech developing a pipeline of first in class cell therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised over a quarter million in funding to continue advancing their clinical programs. The Opportunity: The VP, Clin Ops will play a critical role in the designing and implementing clinical trial protocols to advance their early phase cell therapy programs. Reporting to the Chief Medical Officer, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies in a timely manner. Responsibilities: 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 5+ 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

US$285000 - US$325000 per year
San Francisco
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VP, Clinical Operations

Job Type: Full-time Salary: $300K - $350K Location: San Francisco Bay Area ***Must be local to SF Bay Area to be considered for this position.*** Company Summary: A pre-IPO clinical stage biotech developing cell therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised over a quarter million in funding to continue advancing their clinical programs. The Opportunity: The VP, Clin Ops will play a critical role in designing and implementing clinical trial protocols to advance their early phase cell therapy programs. Reporting to the Chief Medical Officer, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies in a timely manner. Responsibilities: 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 10+ years of oncology (cell therapy/ADC) experience (insourced trial experience a bonus) 5+ years of leadership experience at a small biotech Proven experience as a Sr. or Executive Director, Clinical Operations at a small (> 250 people) biotech A working knowledge of ICH GCP guidelines Benefits: Pre-IPO biotech company & LTIs Competitive salary with comprehensive benefits (100% medical coverage) 401K contribution

US$300000 - US$350000 per year
San Francisco
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Clinical Operations Manager - SG

Our client is an international biopharmaceutical company that specialises in developing neurology drugs. They are currently seeking an experienced Clinical Operations Manager to be based in Singapore, who is passionate about driving success and innovation. This key position offers an opportunity for personal growth and leadership development while contributing significantly to neurology-focused projects. Responsibilities: You will oversee critical aspects of clinical trial management ensuring adherence to Good Clinical Practice. Your expertise as a Clinical Project Manager will be instrumental in executing project plans from conception through completion. With your strong background managing Neurology (CNS) related trials, you'll play an essential role advancing research with life-changing potential. Requirements: Bachelor's degree in related field. At least 4 years of project management experience, with experience in Neurology studies Good communication skills and team spirit Excellent organizational and leadership skills. Proven ability to manage multiple projects and priorities simultaneously. If you are interested, please apply with your CV attached.

Negotiable
Singapore
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CTM

Job Title: Clinical Trial Manager Compensation: $145,000-$165,000 + Bonus + Equity Location: San Diego, CA About Us: We are partnered with an innovative Neurology-focused Biotechnology company that is looking for their next star CTM. They have a robust pipeline of early to mid-phase trials and need to begin expanding their team. This is a great opportunity to join a cutting-edge company at the ground floor and progress further in your career. Position Overview: The Senior Clinical Trial Manager will be overseeing planning and execution of clinical trials. This role needs a candidate with strong leadership and management experience that strives for a high quality of work while maintaining efficiency in their work. The ideal candidate will properly ensure that the trial is compliant with all company standards and regulatory requirements. Key Responsibilities: Oversee clinical trial planning and execution from beginning to end Develop and manage budgets, resources, and timelines Maintain compliance with company standards and regulatory requirements Oversee the selection and management of clinical trial sites and vendors. Collaborate with cross-functional teams, including clinical operations, data management, biostatistics, and regulatory affairs. Monitor trial progress and implement corrective actions as needed. Prepare and present trial updates to senior management and stakeholders. Mentor and train junior staff members. Qualifications: Bachelor's degree in life sciences, nursing, or a related field (advanced degree preferred). Minimum of 5 years of experience in clinical trial management, with at least 3 years in a senior or lead role. In-depth knowledge of clinical trial processes, regulations, and best practices. Strong leadership and project management skills. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Proficiency in clinical trial management software and tools. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. 401(k) with company match. Generous paid time off and holidays. Professional development opportunities. A collaborative and supportive work environment. How to Apply: Interested candidates should submit their resume to zachary.pittard@phaidoninternational.com

US$145000 - US$165000 per year
La Jolla
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Director of Clinical Operations

Director of Clinical Operations New York City, NY (Hybrid) Compensation: $220,000-$260,000 Company Summary: We have partnered with a leading biotech company that is committed to pushing boundaries of scientific discovery and accelerating drug development. This company has a robust oncology pipeline, now specializing in ADCs. With numerous approved treatments and award winning leadership this company stands out from the rest. Primary Responsibilities: Lead and manage global clinical operations team from design to closure Ensure adherence to SOPs and ICH/GCP guidelines. Oversee study timelines, budget, and conduct. Qualifications: Minimum of 10 years of experience in clinical operations on the sponsor side 8+ years in Oncology Experience with phases 1-3 This company offers a competitive compensation package: Annual bonus Equity package 401(k) match program Health/Vision/Dental/Life Insurance If you're interested in this position, please apply now!

US$220000 - US$260000 per year
New York
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Associate Director Clinical Operations

Associate Director Clinical Operations Washington D.C. (Hybrid) $135,000-$175,000 Job Description EPM is partnered with a leading Contract Research Organization (CRO) dedicated to advancing clinical research and improving patient outcomes. Our partner is renowned for its innovative approach, cutting-edge technology, and commitment to excellence in clinical trials. With a global presence and a diverse portfolio of therapeutic areas, they offer a dynamic and collaborative environment for professionals passionate about making a difference in healthcare. Join a team that values integrity, innovation, and impact, and be part of a mission to transform clinical research. Key Qualifications Bachelor's degree in Life Sciences, Nursing, or a related field; advanced degree preferred. Minimum of 10 years of experience in clinical operations, with at least 3 years in a leadership role. Proven experience in monitoring and remote data review. Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements. Excellent leadership, communication, and interpersonal skills. Ability to manage multiple projects and priorities in a fast-paced environment. Experience with budget management and resource allocation. Proficiency in clinical trial management systems (CTMS) and other relevant software. Key Responsibilities: Oversee the planning, execution, and management of clinical trials. Lead and mentor a team of clinical operations professionals. Ensure compliance with GCP, regulatory requirements, and company SOPs. Collaborate with cross-functional teams to achieve project goals. Manage budgets, timelines, and resources effectively. Build and develop a team of CTM's and CRA's to monitor clinical trials Establish Risk-Based Quality Management and Centralized Monitoring processes corporately and for applicable clinical trials. Review protocols to ensure the set-up, review and reporting requirements for KRIs and QTLs can be met and are standardized. Provide technical oversight, guidance and coordination for all the central monitor activities. Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for action resolutions. Benefits Medical Dental Vision PTO

US$135000 - US$175000 per year
Bethesda
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Sr. CTM

Job Title: Senior Clinical Trial Manager Location: San Diego, CA About Us: We are collaborating with a pioneering biotech company specializing in NK cell therapy to revolutionize the scalability and cost-effectiveness of autoimmune drug treatments. With a seasoned leadership team and a robust pipeline of early-phase trials, we are on the cutting edge of medical innovation. We are seeking a Senior Clinical Trial Manager to join our dynamic team and drive continuous progress in our mission to improve patient outcomes. Position Overview: The Senior Clinical Trial Manager will oversee the planning, execution, and management of clinical trials. This role requires a strategic thinker with strong leadership skills and extensive experience in clinical trial management. The ideal candidate will ensure that trials are conducted in compliance with regulatory requirements and company standards, while maintaining the highest level of quality and efficiency. Key Responsibilities: Lead the planning and execution of clinical trials from start to finish. Develop and manage trial budgets, timelines, and resources. Ensure compliance with all regulatory requirements, including FDA, ICH-GCP, and other relevant guidelines. Oversee the selection and management of clinical trial sites and vendors. Collaborate with cross-functional teams, including clinical operations, data management, biostatistics, and regulatory affairs. Monitor trial progress and implement corrective actions as needed. Prepare and present trial updates to senior management and stakeholders. Mentor and train junior staff members. Qualifications: Bachelor's degree in life sciences, nursing, or a related field (advanced degree preferred). Minimum of 3 years of experience in clinical trial management, with at least 1 years in a senior or lead role. In-depth knowledge of clinical trial processes, regulations, and best practices. Strong leadership and project management skills. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Proficiency in clinical trial management software and tools. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. 401(k) with company match. Generous paid time off and holidays. Professional development opportunities. A collaborative and supportive work environment.

US$160000 - US$185000 per year
La Jolla
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Clinical Trial Director

Job Title: Clinical Trial Director Location: Boston, Massachusetts Salary: $180,000-$220,000 Job Summary: The Clinical Trial Director will lead and oversee all clinical trial activities for their lead asset focused in radiopharmaceuticals. This role is critical in ensuring the successful execution of clinical trials, from early-phase studies through to late-stage development. It is also critical in the company's expansion into the US and overseeing their new US sites. The director will report to the Head of Development. Key Responsibilities: Develop and implement clinical operations strategies to support the company's oncology radiopharmaceutical pipeline. Provide leadership and direction to the clinical operations team, ensuring alignment with corporate goals and objectives. Oversee the planning, execution, and management of clinical trials, ensuring they are conducted in compliance with regulatory requirements and Good Clinical Practice (GCP). Manage all aspects of clinical trials, including site selection, patient recruitment, data collection, and monitoring. Ensure timely and accurate reporting of trial progress and results to senior management and stakeholders. Develop and manage clinical trial budgets, timelines, and resources. Ensure all clinical trial activities are conducted in accordance with regulatory requirements and company SOPs. Prepare and submit regulatory documents to ethics committees and regulatory authorities. Lead, mentor, and develop the clinical operations team, fostering a collaborative and high-performance culture. Provide training and support to team members to ensure continuous professional development. Collaborate with cross-functional teams, including clinical research, regulatory affairs, data management, and biostatistics, to ensure the successful execution of clinical trials. Act as a key liaison between the clinical operations team and other departments within the company. Qualifications: Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role. Minimum 7 years of experience in biotech on the sponsor side. Excellent organizational, communication, and leadership skills. Proven ability to manage multiple projects and priorities simultaneously. Preferred Qualifications: Experience in early-phase oncology trials. Radiopharmaceutical experience.

US$180000 - US$220000 per year
Boston
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