Clinical Trial Manager

Hamlyn Williams is partnered with an early-stage biopharmaceutical company that specializes in the development and commercialization of innovative biotherapeutics. They are looking to bring on a Clinical Trial Manager to the team.

Key responsibilities for the CTM Include:

• Supports and coordinates clinical trial activities and manages execution of 1 or more clinical trials/programs to ensure completion according to timelines.

• Manage overall study timelines and oversight of the vendors deliverables.

• Manage CROs and third-party vendors to ensure development and delivery of study documents, plans and manuals.

• Assist and contribute to design of study materials such as assisting with development of IND submission documents, protocols/amendments, ICFs, patient diaries, and other study related materials.

• Prepare, assist, and develop study plans such as monitoring manual, study operations manual, source data verification plan, pharmacy manual, and laboratory manual.

• Coordinate study supplies

• Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision including managing team meetings (Agendas, Minutes, Action Items, Follow Up).

• Develop and review SOPs and processes, guidelines for compliance with global regulatory requirements.

• Provide supervision, coach and mentoring and contribute to hiring new staff.

• Proactively identify risks, develop and implement mitigation strategies.

Minimum Education/Experience:

• BS/BA or equivalent degree

• Ideal candidate will have at least 5 years of relevant experience in either sponsor or CRO (at least 2 years clinical trial management experience).

• At least 1 year of clinical trial experience in oncology required

• Strong track record for successful study initiation and execution

• Experience leading clinical trials preferred

• Working knowledge of policies and procedures that govern clinical research, including but not limited to FDA regulations, Good Clinical Practices, Health Insurance Portability and Accountability Act (HIPAA)

•Experience managing CROs and third-party vendors

• Experience in Finance Management (Budget forecasting, review of SOW, invoices and accruals)

• Experience working with EDC, CTMS, and eTMF systems.

Skills & Abilities:

• Self-motivated and able to thrive in a fast-paced, start-up environment.

• Skilled in communicating effectively, both written and verbal.

• Must have exceptional leadership skills, including motivation and delegation.

• Ability to establish and maintain effective and productive /working relationships with all employees, in a variety of organizations.

• Exceptional customer service and people skills.

• Attention to detail.