Clinical Project Manager

Job Title: 

Reports to:

FLSA Status:  

Location:

Clinical Project Manager

VP Strategy & Operations

Full-time

Rockville, MD

Job Purpose Summary

The Clinical Project Manager is responsible for participating in the planning and execution of member projects while adhering to budget, scope and timeline requirements and applicable regulations, including FDA and ICH.

 

Education Requirements:

Bachelor’s degree in a relevant scientific discipline

 

Work Experience:

At least 5 years of clinical trial/clinical operations experience with evidence of increasing responsibility within the biotech/pharmaceutical or CRO industry. Previous clinical trial monitoring experience desired.

 

Job Duties and Responsibilities:

  • Work closely with VP of Strategy & Operations to manage propriety projects for member organizations.
  • Provide overall operational and strategic input into clinical trials that include, but are not limited to: Investigator selection, investigator agreements, clinical planning tools, protocol development, case report form (CRF) development, IRB submissions, informed consent form (ICF) development, and training materials.
  • Actively involved in the execution of clinical trials from protocol design to the final clinical study report.
  • Manage timelines, budgets, clinical sites, vendors and deliverables while maintaining quality and regulatory compliance.
  • Communicate with clinical trial sites regarding logistics including contract agreements, support materials and training.
  • Plan, support and coordinate events as required by senior leadership.
  • As needed assist with any company-wide administrative needs.
  • Other duties and responsibilities may be assigned.

 

Knowledge/Skill/Abilities:

  • Works well independently and in a team-oriented, collaborative environment.
  • Ability to work on complex or multiple projects with minimal supervision.
  • Thorough knowledge of FDA/ICH and EU regulatory requirements and guidelines.
  • Strong oral and written communication skills, including fluency in technical scientific language and writing; demonstrated positive interpersonal skills; ability to actively maintain good professional relationships and effectively present information to management and general staff.
  • Good problem-solving, analytical, and organizational skills.
  • Self-motivation and the ability to work in a fast-paced environment with top performers.
  • Knowledge of basic finance/accounting/budgeting processes.

 

Supervisory Responsibilities

None

 

Travel

0-20%

 

Salary & Benefits

Commensurate with experience and aligned with US bench-marked ranges for a research-based non-profit of this size and complexity.

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