Sr. / Dir Clinical Operations

Gaithersburg, MD
Sep 23, 2019
Required Education
Bachelors Degree
Position Type
Full time

Summary of Position:

Lead clinical operations and ensure successful completion of all clinical trials and related clinical trial milestones within established timelines and budgets and in accordance with global regulatory standards.

Essential Functions:

  • Provide input for clinical development plans including creation of various clinical trial scenarios along with associated timelines, risks and costs.
  • Work closely with Program Management and the Chief Medical Officer to align operational strategies with corporate goals.
  • Oversee preparation of clinical documents such as protocols, consent forms, monitoring plans, study reports etc.  and contribute to their writing and review.
  • Review and approve clinical study conduct documents and electronic systems
  • Oversee the development, implementation and utilization of relevant clinical systems to ensure Trial Master Files are audit ready and other relevant information is easily accessible.
  • Supervise the selection and management of CROs and other clinical vendors and oversee clinical trial processes to ensure exemplary study conduct and data quality.
  • Develop strategy and action plans for risk mitigation and resolution of any problems that arise.
  • Develop and update clinical budgets and timelines and analyze variances in coordination with Program Management and Finance.
  • Develop and review department policies, SOPs and quality metrics, ensuring operational excellence through ongoing evaluation and improvement of clinical processes and systems.
  • Maintain a collaborative and innovative culture through the development of productive working relationships across organizational functions and regions.

Job Requirements (Essential knowledge, skills and attributes):

  • Bachelor’s degree required, preferably in life science area. Advanced degree/ clinical research certification desirable.
  • Detailed knowledge of the drug development process along with clinical operations management experience. Vaccine experience strongly preferred.
  • At least 7 years of experience in clinical operations related roles of increasing complexity.
  • Successful management of a variety of studies, Phase 1-global Phase 3, in a CRO or bio-pharma setting.
  • Prior successful management of CROs and/or other vendors.
  • Experience and expertise in preparation of clinical protocols, regulatory documents, SOPs, and training materials.