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.
- 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 email@example.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.