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Job Details

Clinical Trials Manager

Location
Cary, NC

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CLINICAL TRIALS MANAGER - POSITION SUMMARY
Responsible for managing the activities of several clinical studies including
assist
in the development of study related documents, study site management
and
patient data monitoring. Provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
ESSENTIAL FUNCTIONS
Assist in the development and management of
company sponsored
clinical trials
Assist in reviewing completed assignments by members of the clinical development group
Assist in the development and management of revisions to
study related
documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools.
Provide support in site recruitment, site initiation, site payments and site close-out.
Help to oversee
training
of new clinical site staff or site training for protocol amendments.
Liaise with
regulatory
department for collection of updated regulatory documents as needed.
Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
Assist in the training of clinical development group staff.
Prepare and update clinical data PowerPoint slides for Investigator’s meetings, quarterly board meetings, R&D meetings
Lead/moderate DSMB teleconferences, monthly PI
and
Study Coordinator teleconferences.
Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
Other duties as assigned
EDUCATION/EXPERIENCE REQUIREMENTS
BA/BS degree with 3-5 years working experience in biological science.
Proficiency in MS Word, Excel, PowerPoint, Outlook
Excellent written/oral communication skills as well as strong organizational and multi-tasking skills.
REQUIRED COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES
Understand the
job specific
system and processes as defined by the company’s SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
Maintain corporate confidentiality at all times.

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