What You’ll Do:

The Clinical Trial Manager will provide project support to team members by leading and/or participating in the daily management of clinical trial activities. Successful candidate will be working closely with and will be responsible for oversight of study activities through our CROs and service providers, including study start-up, conduct, and completion.

This position provides an opportunity to join a rapidly growing Clinical Operations organization and contribute substantially to the building of the department and the successful implementation of trials. 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Perform as the lead interface with the CRO regarding status of project activities and deliverables (including but not limited to site identification and selection, pre-study activities, enrollment, management/conduct, database lock, post-study activities)
• Collaborate with the cross-functional clinical trial team to review and prepare various clinical study documents including but not limited to study protocol, model informed consent forms, and study plans
• Lead day-to-day management of external vendors, as needed, to support the trial design and implementation
• Review and approve internal and external vendor study plans and processes, as applicable
• Review monitoring reports and interact with CRO to ensure the quality of monitoring and site management
• Work with cross-functional team to ensure data query management and data retrieval is taking place in a timely manner
• Review deviation listings and site audit reports and work with team to resolve site issues (e.g., staff retraining, additional resources)
• Maintain and ensure the quality and completeness of study master files in compliance with GCP
• Lead Clinical Study Team meetings internally, and/or with CRO and service providers

Required Qualifications:

• Work experience to include a minimum of 6 years clinical trial experience with a solid understanding of functional area responsibilities associated with the clinical development process
• Good working knowledge of ICH-GCP guidelines and regulatory requirements for clinical trial management
• Must have strong clinical study management, communication (oral and written), and analytical skills
• Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently
• Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment
• Demonstrated ability to effectively manage external vendors & CROs
• Advanced proficiency in Microsoft Office and Microsoft Project or other Project Management software
• Demonstrated strong written and verbal communication skills
• Must be able to travel 

Education:

• BA/BS; Life Science degree a plus