Senior Clinical Project Manager

Proclinical is currently recruiting for a Senior Clinical Project Manager with a leading biotechnology company located in Gaithersburg, MD. As the Sr. Clinical Project Manager, you will require solid understanding of all aspects of industry sponsored clinical trials Phases 1/2. Individuals suited for this position are highly independent, organized, dedicated to their programs and motivated by achieving organizational goals.

Job Responsibilities:

• Provide matrix management of functional area representatives to cross-functional teams.
• Lead/oversee cross-functional CTTs for early phase studies.
• Define and manage accountabilities for all CTT members.
• Collaborate with cross-functional area heads to ensure proper resourcing for assigned trials.
• Support development of Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP).
• Develop outsourcing specs for vendor requests for proposal and scope of work agreements.
• Manage selection of study vendors for assigned studies.
• Manage the vendor(s) throughout the life of assigned clinical trial.
• Provide input on investigational site selection in collaboration with Clinical Development and vendors.
• Review and refine Clinical Operations Plans/Vendor Oversight Plans.
• Provide oversight of monitoring activities through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs.
• Lead ongoing review of data to ensure quality and consistency.
• Participate in planning and conduct of investigator meetings and ad boards, etc.
• Develops and manage program budget(s) and oversees site agreement/budget negotiation process, and manage program timelines.
• Oversee the submission of trial-related and essential documents to the Trial Master File.
• Identify and provide solutions to clinical trial issues or risks.
• Provide input into non-project related activities and development of procedures/SOPs.
• Facilitate training to clinical study teams on protocol specific topics.
• Participate as appropriate in internal and external audits.

Skills and Requirements:

• BS preferred.
• Thorough understanding of country level regulations, ICH and GCP guidelines.
• Understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, CMC and regulatory affairs.
• Ability to lead a cross-functional team in a matrix environment.
• Strong interpersonal, verbal, written communication and negotiation skills.
• Proven complex problem solving and decision-making skills.
• Ability to travel occasionally (internationally and domestically).
• Minimum of 6 years progressive experience in clinical operations including 3 years of clinical project management or equivalent.

If you are having difficulty in applying or if you have any questions, please contact David Nixon at or d.nixon@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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