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

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 CRO trial management 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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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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Manager Clinical Operations- Medical Device

Manager, Clinical Operations (Medical Device) Location: Plano, Texas Job Description Company Overview: A global manufacturer of specialty medical products is seeking a Manager, Clinical Operations to join its team. With a strong reputation for delivering best-in-class medical devices across interventional radiology, vascular surgery, interventional cardiology, and oncology, this company is committed to improving patient outcomes through percutaneous, image-guided procedures. The organization operates with a values-driven culture, fostering collaboration and innovation. Position Overview: The Manager, Clinical Operations will oversee all clinical activities related to a portfolio of clinical studies and lead daily in-house operations. This role will independently manage multiple clinical studies, provide leadership to a team of Clinical Affairs Managers, and drive strategic clinical initiatives. Key Responsibilities: Provide leadership in the execution of pre-market and post-market clinical studies. Represent the company's clinical research interests within the region and gather insights from customers and regulatory authorities. Build and maintain strong relationships with internal and external stakeholders. Manage global and local clinical research projects across the company's portfolio. Ensure clinical programs align with applicable regulations, guidelines, and policies. Lead development and revisions of clinical study protocols, Instructions for Use (IFU), Case Report Forms (CRFs), and other essential documentation. Oversee clinical study accuracy, compliance, and budget management. Act as a key representative during audits and regulatory interactions. Collaborate with cross-functional teams to drive clinical and company-wide initiatives. Oversee third-party vendors such as Contract Research Organizations (CROs) and core labs. Support post-clinical activities and product market launches. Qualifications & Skills: Bachelor's degree in engineering, life sciences, or a related medical/scientific field (advanced degree preferred). Minimum of 7 years of Clinical Research experience, including 5+ years in a leadership role. Professional certification (e.g., ACRP, SOCRA) preferred. Medical device industry experience, particularly in interventional radiology and/or cardiovascular fields. Strong experience managing direct reports and clinical teams. Proven expertise in clinical trial design, execution, and regulatory compliance. Cost-center and study budget management experience. Global clinical trial strategy and execution experience. Product development exposure, including global clinical strategy development. Ability to travel up to 40%. This is an exciting opportunity to take on a leadership role in a growing clinical team and contribute to innovative medical advancements.

Negotiable
Dallas
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Clinical Contracts & Budgets Specialist

Job title: Clinical Contracts & Budget Specialist Location: Diegem, Belgium Role Overview: In this position, you will oversee the development, negotiation, and finalisation of site agreements and budgets for medical device clinical trials in various therapeutic areas. This role requires collaboration with internal stakeholders and coordination with external health care institution staff. Key Responsibilities: Drafting, negotiating, analysing, escalating, and finalising site agreements and budgets. Speeding up negotiations by applying budget parameters. Working with legal teams to negotiate contracts. Ensuring regular communication and escalation to streamline the planning, execution, issue resolution, and management of Site/Investigator agreements. Balancing Site Activation requirements with contracting turnaround times to facilitate study site authorisation. Essential Qualifications: Bachelor's degree or equivalent experience. At least 2 years of experience in managing clinical site contracts and budgets. Desired Qualifications: Strong time management skills, with the ability to prioritise multiple tasks independently. Capability to work independently and proactively address and resolve issues. Excellent analytic and organisational skills. Proficient communication skills in French/English, both written and verbal. Demonstrated interpersonal skills, including being proactive, customer-focused, and an independent critical thinker. If you feel this role is the perfect fit, take action now!

Negotiable
Diegem
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Technical Support Specialist

Are you a problem-solver with a passion for helping others? We are looking for a Technical Support Specialist who will provide vital assistance to patients relying on life-saving medical equipment. You will be part of a role that truly makes a difference in patients lives, providing essential support when they need it most. With a dedicated and supportive team by your side, you will receive comprehensive training to ensure you feel confident and equipped to excel in your position. You Will Be Responsible For: Handling inbound patient calls, offering support and troubleshooting assistance. Ensure accurate documentation of interactions and technical issues. Collaborate with service teams to maintain equipment functionality. Deliver patient-focused support with empathy and professionalism. What We Are Looking For: Bachelor's degree in health sciences or related field. Fluent Polish speaker with English proficiency. Experience in technical support or health care (medical device knowledge is a plus). Strong IT skills, including MS Office and data management. Ability to work independently during night shifts in a fast-paced environment. If you are looking for a position that will allow you to impact the lives of patients globally, then this is the position for you. Apply today and become part of a company committed to improving patient care and safety.

Negotiable
Poland
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VP Clinical Affairs

VP Clinical Affairs Salary: ($200,000-$300,000) USA (remote) This medical device company has ongoing studies in Europe for a very promising Tricuspid Valve Repair device. As they're expanding into the US for domestic studies, they are seeking a VP Clinical Affairs to head-up clinical and drive these studies within the US. Responsiblities: Lead strategy, design, and execution of clinical studies Oversee Cliinical Affairs team, while partnering with cross-fucntional teams An ideal candidate for this role will have: 12+ years of clinical affiars experience 6+ years in structural heart (ideally in Tricuspid) This company offers a competitive compensation package: Annual bonus Pre-IPO equity PTO package Health, vision, dental insurance If you're interested in this opportunity, please apply now.

US$200000 - US$300000 per year
United States of America
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Clinical Project Manager

Clinical Project Manager Salary: ($130,000-$170,000) San Francisco Bay Area (hybrid) This privately-held medical device company is leading the way in mitral and tricuspid valve repair. They're backed by a larger parent company that has a very impressive leadership team - so it's no suprise they recently recieved $100M+ in funding. As they're ramping up their mitral and tricuspid programs, they are looking to build out their clinical affairs team. They're currently seeking a Clinical Project Manager to lead the studies with the VP Clinical Affairs. Responsiblities: Support clinical affairs team to ensure clinical studies are ran effectively and efficiently Manage CROs and oversee site start-up Help prepare study documents Requirements: 4+ years of experience managing medical device studies (within heart valve) 7+ years of experience on the sponsor side BA/BS This company offers a competitive compensation package: Annual bonus Equity package Competitive PTO If you're interested in this position, please apply now!

US$130000 - US$170000 per year
San Francisco
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Freelance Clinical Trial Lead (m.w.d)

We have a current opportunity for a Freelance Clinical Trial Lead on a contract basis. The position will be based in Ireland. The ideal candidate: Is immediately available at 1.0 FTE Has at least 5 years experience in Clinical Research, with at least 2 as a CTM or equivalent Has oncology experience For further information about this position please apply with your CV. Please note this is a *fixed term contract* with a flexible end date.

Negotiable
Republic of Ireland
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Associate Director of Clinical Operations

Job Title: Associate Director of Clinical Operations Location: Seaport, Boston, MA Company Overview: We're partnered with a biotech that's dedicated to developing innovative therapies for neurodegenerative diseases. Their mission is to improve the lives of patients through cutting-edge research and clinical development. Position Overview: The Associate Director of Clinical Operations will play a pivotal role in overseeing and managing clinical trials focused on neurodegenerative diseases. This position requires a strategic leader with extensive experience in clinical operations, project management, and regulatory compliance. The successful candidate will collaborate with cross-functional teams to ensure the successful execution of clinical trials from initiation to completion. Key Responsibilities: Clinical Trial Management: Oversee the planning, implementation, and management of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements. Team Leadership: Lead and mentor a team of clinical operations professionals, fostering a collaborative and high-performance work environment. Vendor Management: Select, manage, and oversee Contract Research Organizations (CROs) and other external vendors to ensure quality and compliance with study protocols. Regulatory Compliance: Ensure all clinical trials are conducted in accordance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines. Data Management: Collaborate with data management teams to ensure accurate and timely data collection, analysis, and reporting. Risk Management: Identify and mitigate risks associated with clinical trials, implementing corrective actions as necessary. Budget Oversight: Develop and manage clinical trial budgets, ensuring cost-effective use of resources. Stakeholder Communication: Serve as the primary point of contact for internal and external stakeholders, providing regular updates on trial progress and addressing any issues that arise. Quality Assurance: Implement and maintain quality management systems to ensure the highest standards of clinical trial conduct. Qualifications: Education: Bachelor's or Master's degree in Life Sciences, Nursing, or a related field. Advanced degree (Ph.D., M.D.) preferred. Experience: Minimum of 10 years of experience in clinical operations within the biotechnology or pharmaceutical industry, with a focus on neurodegenerative diseases. Leadership: Proven track record of leading and managing clinical operations teams. Regulatory Knowledge: In-depth knowledge of GCP, FDA regulations, and other relevant guidelines. Project Management: Strong project management skills with the ability to manage multiple priorities and projects simultaneously. Communication: Excellent written and verbal communication skills, with the ability to effectively communicate with diverse stakeholders. Problem-Solving: Strong analytical and problem-solving abilities, with a proactive approach to identifying and addressing challenges. 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

US$170000 - US$200000 per year
Boston
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Head of Clinical Operations

Job Title: Head of Clinical Operations Location: Cambridge, Massachusetts Salary: $250,000-$290,000 Job Summary: The Head of Clinical Operations will lead and oversee all clinical operations activities, ensuring the successful execution of clinical trials for radiopharmaceutical related trials. This role requires a strategic leader with extensive experience in clinical operations, project management, and regulatory compliance. The successful candidate will work closely with cross-functional teams to drive clinical development programs from initiation to completion. 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 15 years of experience in clinical trial management, with at least 8 years in a leadership role. Minimum 5 years of experience in radiopharmaceuticals, 10 years in early phase oncology. Excellent organizational, communication, and leadership skills. Proven ability to manage multiple projects and priorities simultaneously.

US$250000 - US$290000 per year
Boston
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PA

Personal Assistant - Pharmaceutical Sector Egham - 2/3 hybrid model Salary ยฃ50 - ยฃ60k + corporate benefits Are you organized, detail-oriented and passionate about supporting a dynamic corporate team? We are seeking an exceptional Personal Assistant (PA) to join our client's progressive pharmaceutical company based in Egham, United Kingdom. This is your chance to be part of an innovative organization committed to developing products that help patients live fuller lives. As a PA within this firm, you will: Support the clinical team and work closely with their Director of Global Clinical Affairs Manage complex schedules and coordinate travel arrangements Ensure smooth communication between internal departments as well as with external partners Handle confidential information with discretion at all times Assist with project management tasks to support executive-level personnel Liaise with the global Executive Team UK/EU To excel in this role, candidates should demonstrate: 5+ years of working in a similar position with the preference of coming from a Pharmaceutical/CDMO organisation Have some understanding of the workings of a clinical team Exceptional Organizational Skills: Maintain calendars efficiently while juggling multiple priorities. Effective Communication Abilities: Convey messages clearly both verbally and written across different levels of the business. Project Management Aptitude: Keep projects on track through meticulous planning and coordination skills. Discretion & Confidentiality Awareness: Safeguard sensitive data relevant to Corporate Services operations. 2 stage interview process with slots confirmed for the week commencing 3/2/25

Up to ยฃ60000 per annum
Egham
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Clinical Program Manager, APAC

Salary: $145-165K Company Summary: One of the best funded pre-IPO biotechs with upwards of half a billion in funding is growing their clinical operations team as they continue to expand their oncology trials on a global scale. With an office in Hayward, they have Nobel prize winning science and experienced former Big Pharma C-suites executives at the helm to back it. Their pipeline has 7 programs in development across 12 indications and their lead candidate is heading into Phase 3. The best fit for this role will be a team leader who has APAC trial management experience and the ability to communicate in a language relevant to the region (Korean or Japanese). ***** Candidate must be able to go on-site in Hayward, CA three times a week.**** The Clinical Program Lead will be responsible for Reporting into the Sr. Director or Director of Clinical Operations and working in collaboration with Clinical Ops and Clinical R&D teams. Leading and managing Clinical Ops Study Management team and providing direction to cross-functional study teams to ensure successful study execution. Ensuring the design, monitoring, data interpretation and reporting activities related to the conduct of clinical studies are conducted in accordance with applicable regulations, ICH/GCP, APAC, PMDA, regulations and Standard Operating Procedures (SOPs). Managing ancillary (non CRO) vendor relationships and performance. Providing updates on study to internal stakeholders. Ensuring accurate and complete filing within clinical/reg/finance/safety systems. Complying with internal processes, SOPs, clinical & insurance supply management, and import/export requirements. A candidate for this role MUST haveโ€ฆ Working fluency in Korean or Japanese and English 8+ years of experience establishing a clinical program and/or managing clinical trials in APAC region 5+ years of sponsor experience 3+ years of recent oncology or immunology experience 2+ of experience managing direct reports PhD, Master's Degree, or a Bachelor's Degree in life sciences, healthcare, or related field preferred. Benefits: Working with a world class leadership team including a former CMO responsible for a blockbuster dru Nobel Prize winning science Generous PTO and holiday policies PLUS one-week summer and winter shutdowns Daily subsidized lunch program when on site 401K + stock Medical, Dental, & Vision and more! If you are interested in this Clinical Program Manager role, feel free to reach out!

US$145000 - US$170000 per year
San Francisco
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