Senior Clinical Trial Manager

SENIOR CLINICAL TRIAL MANAGER (6-months)

SUMMARY:
Clinical Research Professional needed to support clinical trial execution and compliance activities for an innovative biotech organization.

DUTIES & RESPONSIBILITIES:
* Trial execution and compliance oversight
* CRO and other vendor management
* Study start-up activities, including site selection and activation, contract and budget negotiations, regulatory compliance and related submission support, trainings, etc.
* Support study document development and management, audits and metrics tracking
* Monitoring visit report reviews
* Other duties, as required

QUALIFICATIONS & REQUIREMENTS:
* 7 years of drug trial Clinical Operations experience, including at least 3 years of experience in drug trial management as a Clinical Trial Manager, Clinical Project Manager or Equivalent. Experience should include some degree of study management for small biotech organizations, as well as studies involving ratings and scales.
* Excellent Clinical Research Vendor Management experience, including management of CROs
* Excellent written, verbal and interpersonal communication skills, as well as computer skills including EDC, eTMF, CTMS, etc.
* Relevant Bachelor's Degree

LOCATION:
Work will be performed remotely from the eastern or central United States. Some travel to study sites may be required.

Job Types: Full-time, Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Education:

• Bachelor's (Preferred)

Experience:

• clinical operations: 7 years (Preferred)
• clinical trial manager: 3 years (Preferred)
• psychiatric: 3 years (Preferred)
• studies involving ratings and scales: 3 years (Preferred)
• clinical research vendor management: 3 years (Preferred)

Work Location: Remote