Senior Clinical Trial Specialist (Contract)

The role

This contract role supports the Clinical Trial Manager in running clinical studies from site start-up through close-out, following SOPs, GCP and regulatory guidelines. The work covers meetings, tracking site milestones and budgets, study documents, TMF upkeep and data review before database lock. The role may convert to permanent.

What you will do

• Support the Clinical Trial Manager in day-to-day management of assigned clinical trials
• Prepare agendas, minutes and materials for kick-off, investigator and vendor meetings
• Track purchase orders, invoices, site budgets, investigator payments and CTAs
• Track site start-up, enrollment, dosing, monitoring and close-out milestones
• Maintain study tools for team training, recruitment materials, lab kits and vendor access
• Support oversight of study vendors, including invoice review
• Help review documents such as informed consent forms, study binders, management plans and protocols
• Manage and maintain the study team SharePoint
• Assist with site oversight, data entry timeliness and monitoring trip report follow-up
• Help maintain the TMF and review study data before database lock

Required qualifications

• B.A. or B.S. degree
• 4+ years of experience in a biotech or pharmaceutical organization
• Knowledge and training in Good Clinical Practice (GCP)
• Proficiency with Microsoft Outlook, Word and Excel
• Independently motivated, detail oriented, good problem-solving ability
• Excellent written and verbal communication skills
• Flexible and able to adapt to new situations
• Ability to work effectively from a virtual home office
• Willingness to work non-traditional hours when needed
• Occasional travel may be required

Nice to have

• Experience working with clinical sites, principal investigators, clinical operations staff and CROs

Benefits

• Access to a comprehensive benefits package through the employer of record
• Medical plans, including PPO and EPO options, after 30 days
• Dental and vision coverage after 30 days
• 401(k) may be available
• Wellness programs may be available
• Other discounts may be available

Before you apply

• Contractors are employed through a third-party agency that serves as the employer of record
• Contract-to-hire: the role is temporary with potential to convert to permanent
• The posting states the company will not assign referral rights for unsolicited resumes from recruitment agencies

About the company

Centessa Pharmaceuticals is a clinical-stage company, a wholly owned subsidiary of Eli Lilly and Company, developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. It is headquartered in Boston, Massachusetts.