Clinical Development and Operations Fellow (Connecticut, CT)

We are looking for a Clinical Development and Operations Fellow to gain hands-on experience in clinical trial management while deepening their understanding of the drug development process. This fellowship provides a unique opportunity for a Doctor of Pharmacy graduate to work closely with Therapeutic Area Directors and Clinical Trial Managers (CTMs), contributing to trial preparation, conduct, and closeout under experienced mentorship. Through rotations and shadowing across functional groups, fellows will gain broad exposure to clinical development and operations, regulatory processes, and specialized roles in clinical trial execution.
 

Trial Preparation, Conduct, and Closeout:

• Select trial sites and oversee study delivery according to protocol, timelines, and ICH-GCP standards.
• Lead and support trial teams and sites in the preparation of trial documents, contracts, and necessary approvals.
• Ensure all regulatory requirements are satisfied before trial or site initiation.
• Manage external suppliers as needed to support trial operations.
• Develop, manage, and review trial budgets to maintain financial oversight, with timely updates for trial changes.
• Provide trial-specific training to internal and external partners according to the Trial Training Plan.
• Collaborate with Site Monitoring Leads and Clinical Research Associates (CRAs) to ensure trial site compliance with GCP, local regulations, and BI SOPs.
• Oversee trial supply distribution and ensure timely data entry, cleaning, and database lock (DBL).
• Serve as a trial contact for CRAs, investigators, and site staff.
• Manage the collection, archiving, and compliance of trial documents for the electronic Trial Master File (eTMF) and Clinical Trial Report (CTR) Appendices.

Management and Relationship Responsibilities:

• Build and maintain relationships with external experts and investigational sites, coordinating cross-functional collaboration with Clinical Operations and Medical Affairs.
• Support CRAs in site contacts and ensure alignment across trial management topics.
• Represent trials at local and regional levels, providing regular updates and contributing to cross-functional working groups.

• Education:

  • Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned before the fellowship start date.

• Skills and Qualifications:

  • Ability to perform MEDLINE and EMBASE literature searches.
  • Strong interpersonal, active listening, and problem-solving skills for effective team collaboration.
  • High motivation, initiative, and adaptability to contribute to multiple therapeutic areas.
  • Excellent verbal and written communication skills.
  • Proven ability to handle multiple tasks in a dynamic, high-volume environment.
  • Strong computer skills, including proficiency in Outlook, Word, PowerPoint, and Excel.
  • Foundational understanding of corporate structure, regulatory considerations, and the drug development process.

• Curriculum Vitae (CV).
• Letter of intent describing how this fellowship aligns with career goals (uploaded under "My Documents, Additional Attachments").

This is a full time position