Clinical Project Manager

Location: Baltimore, MD.

Position Summary:

The CPM supports the Director of Clinical Operations in the planning and management of overall clinical operations execution for assigned clinical trial(s), including timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and relevant ICH/GCP guidelines, and in alignment with department strategies and goals.

Major Duties and Responsibilities:
  • Provides clinical operations support to the Director in order to achieve all deliverables from clinical protocol (CP) to clinical study report (CSR).
  • Reviews and refines study level Clinical Operations Plans.
  • May develop outsourcing specifications for vendor requests for proposal and scope of work agreements.
  • May participate in and guide study team in vendor selection.
  • May manage the vendor(s) throughout the life of assigned clinical trial(s).
  • May participate in review of data management-related deliverables from external vendors (e.g. review of CRFs, review of edit specifications, review of CRF completion guidelines, etc.).
  • May select investigational sites with input from Director.
  • May support Director with the site agreement/budget negotiation process.
  • Oversees the collection of trial-related and essential documents.
  • Assists in the planning and conduct of investigator meetings and ad boards, etc.
  • Oversees investigative sites’ adherence to pertinent regulations through review of monitoring reports, and communications with investigators, study site personnel, and CRAs.
  • Participates in ongoing review of data to ensure quality and consistency.
  • Identifies and provides solutions to clinical trial operational issues.
  • Provides input into non-project related activities and development of procedures as requested.
  • May mentor staff and serve as a resource for new employees.
  • Provides or facilitates training to clinical study teams on protocol specific topics.
  • Participates as appropriate in internal and external meetings.
  • Other duties as assigned.

Requirements/ Qualifications:

Education:
  • University degree in biologic or related scientific discipline
Experience:
  • At least 6 years of biotech and/or pharmaceutical industry experience in human drug development, with demonstrated increasing levels of responsibility, and experience managing clinical projects and/or matrix teams within Clinical Operations.
Special Skills / Abilities:
  • Thorough understanding of country level regulations, and relevant ICH and GCP guidelines.
  • Working knowledge of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
  • Ability to participate in cross-functional teams in a matrix environment.
  • Strong interpersonal and negotiation skills.
  • Strong verbal and written communications and presentation skills.
  • Proven problem solving and decision making skills.
  • Leadership, communication, management and organizational skills; conflict resolution and team building skills.
  • Ability and willingness to travel as needed (< 15%).
Job Complexity:
  • Provides technical solutions to a range of difficult problems.
  • Manages smaller clinical trials or components of global clinical trials.
Supervision:
  • Ability to work independently, with minimal oversight by the Director.
  • Develops approach to solutions and seeks guidance as appropriate.
  • Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.

 


To learn more and to apply, please send your first and last name, a cover letter, and resume to careers@asklepionpharm.com.