Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols.
Participates in protocol review discussions concerning scientific and procedural aspects of study design.
Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision.
With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
With supervision, addresses questions regarding scientific and related procedural issues from Investigators.
With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
Supports priorities within functional area. Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
May be asked to coordinate teams and provide direction.
May lead two or more specific components of departmental strategic initiatives.
Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
Requirements:
PharmD with 2+ years relevant scientific and/or drug development experience
MS with 6+ years relevant scientific and/or drug development experience.
BS or RN with 8+ years relevant scientific and/or drug development experience
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