Senior Clinical Project Manager

Highly Competitive Salary
  1. Permanent
  2. CRA Manager, Project/Study Manager (CSM/CPM), Program Manager / Director
  3. United States
Gaithersburg, USA
Posting date: 20 Jul 2020
CR.PS.30635

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 Paige Sanderson at (+1) 646-367-2618 or p.sanderson@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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