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 Study Lead

Salary: $140-160K Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Study Lead for a hybrid role in San Francisco (Palo Alto). Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior during a year of record layoffs). 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 Clinical Study Lead to drive their pipeline forward. ***** Candidate must be based in SF to be considered.***** The Clinical Study Lead will be responsible for: In house study management of studies within their Vitiligo program Leading the cross-functional study team responsible for study delivery and oversight (as required) for the assigned study Overseeing the set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint etc. May be responsible for CRA and CTAs as direct reports Reporting into the Clinical Program Lead An ideal candidate for this role MUST have… 5+ years sponsor experience 2+ years experience managing studies or trials in house (rare disease or derm preferred) At least 2 years of experience managing direct reports or mentoring junior clin ops tem members 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 High degree of commercial exposure early in your career Being a part of team whose work directly aims to improve the quality of people's lives Great work-life balance If you are interested in this Clinical Study Lead role, don't hesitate to reach out!

US$140000 - US$160000 per year
San Francisco
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VP Clinical Operations

Vice President Clinical Operations Boston, MA (Hybrid) $265,000 - $300,000 Job Description A pioneering precision medicine enterprise, based in the Boston area, is actively seeking a Vice President of Clinical Operations to join its esteemed team. Renowned for leadership in targeted oncology, the company is dedicated to reshaping the landscape of cancer care. Utilizing state-of-the-art technologies, they tailor treatments to meet the unique needs of individual patients. Embracing a collaborative culture, the company fosters innovation, providing an opportunity for professionals to contribute to groundbreaking advancements in precision oncology. The VP of Clinical Operations will hold a pivotal role in steering the evolution of healthcare, leaving a lasting impact on the lives of cancer patients. Responsibilities Strategic guidance and leadership provided to the clinical operations team for clinical trial management and execution Manage vendor selection and ensures compliance with established timelines and financial commitments Ensure cost, quality, and timeliness of multiple therapeutic programs Oversee recruitment, development, and retention of the clinical operations team, prioritizing activities in line with development programs Establish department standards, ensuring regulatory compliance Collaborates cross-functionally with Clinical, Product Development, Biostatistics, regulatory Affairs, Informatics, Legal, and Finance departments Qualifications Minimum of 10 year progressively responsible experience in clinical drug development Minimum of 8 years in a clinical operations management role 12 years of professional experience in pharmaceutical, biotech, CRO environments Hands on clinical operations leadership across all clinical development phases Demonstrated leadership in managing, coaching, and mentoring direct reports Excellent planning, organization, and time management skills, including prioritizing multiple projects Benefits 401(k) with percentage match Medical, Dental, Vision Performance and target based bonuses PTO and Holidays

US$265000 - US$300000 per year
United States of America
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Clinical Trial Manager/Senior Manager

Location: Seoul, Korea Therapeutic Areas: 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 South Korea. 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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Study Start-Up Specialist

Study Start-Up Specialist New Jersey (Hybrid) $90,000-$100,000 Job Description EPM is partnered with a company focused on creating novel therapeutic bi-specific, multi specific, and ADC's for cancer treatment. With their clinical stage assets, the data has been described as "the best I've ever seen" by industry leaders, and they signed a licensing agreement with a big pharma company at the end of last year worth multiple billion dollars. Given their science and financial backing along with the opportunity for growth, it's a really high potential opportunity. They're growing out a new office in New Jersey, so it's a very exciting time to join! Roles and Responsibilities Prepare, compile, and submit regulatory documents and applications required for the initiation of clinical trials (e.g., IND applications) Collaborate with clinical operations and project management teams to identify potential investigational sites for clinical trials Facilitate contract and budget negotiations with investigational sties and vendors Ensure all study-related documents are prepared according to regulatory requirements and company standards Key Qualifications At least 2 years of experience in a study start up focused role at a biotech or pharmaceutical company Experience in developing and maintaining project timelines and coordination cross-functional teams Familiarity with clinical trial protocols, informed consent processes, and study documentation preparation Ability to effectively communicate with internal teams, investigational sites, CRO's, and vendors High level of attention to detail to ensure accuracy and compliance in preparing regulatory documents and study materials Benefits Medical Dental Vision 401(k)

US$90000 - US$100000 per year
United States of America
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Associate Director Program Management

Associate Director Program Management Salary: ($140,000-$185,000) San Francisco Bay Area (hybrid 3+ days per week) My client is a Bay Area based Biotech that is developing cutting-edge treatments in cell therapy. Their pipeline consists of several programs, with a total of over 6 indications in the clinic. They are currently building out their Program Management team and are looking to bring on a cross-functional Associate Director Program Management that will report directly into the Director PM. Responsibilities: Provide cross-functional program management experience to pre-clinical, clinical, regulatory, CMC, etc. Develop and help execute timelines/roadmap for portfolio strategy The ideal candidate for this role will have: 4+ years of experience in cross-functional Program/Project/Portfolio Management Strong understanding of different regulatory bodies globally (FDA, EMA, APAC, etc.) Ability to successfully communicate with different department heads This company provides a competitive total rewards package: Annual bonus Equity Health, vision, dental insurance 401(k) match program Please apply now if you're interested!

US$140000 - US$185000 per year
San Francisco
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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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Director / Sr. Director, Clinical Operations

Salary: $210K-250K Company Summary: A global immuno-oncology focused biotech with an impressive track record is seeking a Director or Sr. Director of Clinical Operations for a hybrid (3 days on site) role located in South San Francisco, CA. Since their first clinical trials in 2006, 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 Director/SD to head up their late phase IO studies. The Director/Sr. Director, Clin Ops 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 - IO or complex trial experience 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 (90% 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 Director/Sr. Director of Clin Ops position, drop a CV!

US$215000 - US$250000 per year
San Francisco
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Associate Director / Director, Clinical Operations

Salary: $210K-250K *** *Must be in SF or local to SF area** Company Summary: A global immunology focused biotech with an impressive track record is seeking an Associate Director or Director of Clinical Operations for a hybrid role located in Palo Alto, CA. Their aim is to create a best-in-class immunotherapy to treat unmet needs within the autoimmune and oncology spaces. Currently, they have 6 indications in Phases II and III, so they are looking for a driven, growth-oriented AD/Director, Clinical Operations to head up their Phase III studies. The Associate Director or 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 / oncology / 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, please apply!

US$210000 - US$250000 per year
San Francisco
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Sr. Clinical Trial Manager

Salary: $150-190K ***Candidates MUST be able to come on-site 3 days a week in South San Francisco*** Company Summary: Working with a clinical-stage biotech company that's looking for a Clinical Trial Manager/Sr. CTM to come into their SSF office on a hybrid/full-time basis. Their mission is to create best-in-class treatments for liver, metabolic, and rare diseases. The CTM/SCTM will play a pivotal role in the oversight and management of their NASH studies. The CTM/Sr. CTM will be responsible for: Reporting directly into the Director, Clinical Operations Managing global 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 2 years of trial management experience REQUIRED Experience in hepatology, metabolic disease, and rare disease therapeutic areas PREFERRED 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 (20% bonus, medical, dental, and vision) Flexible PTO arrangements 401K contribution

US$150000 - US$190000 per year
San Francisco
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Director Clinical Operations

Director Clinical Operations USA (Remote) $200,000 - $235,000 Job Description A Global, commercial stage biotech focusing on creating novel cell therapeies in the oncology space is looking to grow as they hire a Director of Clinical Operations. With a drug already approved (in the US and EU), they are backed by a proven drug platform and tons of financial stability. What makes this opportunity interesting is that they are still in a growth phase, so there is vast opportunity for vertical mobility within. With a robust pipeline, and partners from various large pharmaceutical companies, opportunities like this don't come around often. Key Qualifications Bachelor's degree in a life science related field 10+ years of oncology experience at a Biotech or Pharmaceutical company (not CRO) Regulatory authority inspection experience highly preferred Experience planning and managing T-Cell therapies required 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 Manage, mentor, and oversee the development of new clinical staff and a small number of CTM's Facilitate end to end clinical trial management activies both domestically and globally, including study planning, start up, and execution Oversee vendor selection and manage various CRO's and vendors Define timelines and deliverables while working closely with the Senior Director Clinical Operations 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$200000 - US$235000 per year
United States of America
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Sr. Clinical Trial Manager

Salary: $150-190K ***Candidates MUST be able to come on-site 3 days a week in South San Francisco*** Company Summary: Working with a clinical-stage biotech company that's looking for a Clinical Trial Manager/Sr. CTM to come into their SSF office on a hybrid/full-time basis. Their mission is to create best-in-class treatments for liver, metabolic, and rare diseases. The CTM/SCTM will play a pivotal role in the oversight and management of their NASH studies. The CTM/Sr. CTM will be responsible for: Reporting directly into the Director, Clinical Operations Managing global 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 2 years of trial management experience REQUIRED Experience in hepatology, metabolic disease, and rare disease therapeutic areas PREFERRED 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 (20% bonus, medical, dental, and vision) Flexible PTO arrangements 401K contribution

US$150000 - US$190000 per year
San Francisco
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