Clinical Trial Manager

SUMMARY:

Responsible for leading and managing the operational activities to support planning, initiation, conduct and close out of Phase I-IV studies (domestic and global studies).  Responsible for managing studies run with internal staff as well as using Contract Research Organizations (CROs).

ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:

Ensuring clinical studies are conducted in compliance with FDA regulations, ICH guidelines, and NBI SOPs and policies.

Managing sites and contract service providers (CSPs) for assigned studies.

Mentoring, training, and overseeing CRAs and CTAs on assigned studies.

Developing monitoring plans, on-site monitoring guidelines, forms, and tools.

Also responsible for implementing and enforcing of NBI standard processes across clinical studies.

Managing of CROs, as applicable.

Performing monitoring and co-monitoring visits, as necessary.

Understanding of therapeutic area to participate in technical and study design discussions and providing input to clinical trial outlines, protocols, and clinical study reports.

Working with Medical Directors to resolve subject eligibility and protocol deviation issues.

Participate in data review meetings.

Leading study team meetings and managing study issues.  Developing and managing study timelines in accordance with corporate goals.  Identifying barriers to enrollment and developing recruitment solutions.

Performing additional tasks and duties as assigned.

QUALIFICATIONS:

Requires detailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, and FDA regulations.  Strong organizational skills, interpersonal and team participation skills are essential.  Experience managing CROs and international study experience in Phase II/III studies is required.  Rare disease experience is a plus.  Effectively operate in multi-level matrix environment.

EDUCATION and/or EXPERIENCE:

BS or MS, or RN with a minimum of 5 years clinical experience (monitoring-minimum of 2 years and study management) in pharmaceutical industry/ Biotech or CRO.  In some cases, a combination of education and prior directly related experience may be considered as equivalent.

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