Clinical Research Scientist - III*

This role is with a biotech client that researches, develops, and commercializes antiviral drugs for HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

About the role

This is a 12-month temporary remote assignment based at 369 Interpace Pkwy, Parsippany, NJ 07054.

Responsibilities

• Acquire and utilize knowledge of clinical trial design to develop specific study concept sheets and protocols.
• Participate in protocol review discussions concerning scientific and procedural aspects of study design.
• Prepare study protocols, amendments, specific sections of study manuals, Investigator meeting notebooks, and other documents with appropriate guidance and supervision.
• Contribute to the design and development of CRFs, Data Management Manuals, and Data Analysis Plans with supervision.
• Address questions regarding scientific and related procedural issues from Investigators with supervision.
• Contribute to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
• Assist in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures, and NDAs.
• Support priorities within the functional area; anticipate moderately complex obstacles within a clinical study and implement solutions with guidance.
• Coordinate teams and provide direction as needed.
• Lead two or more specific components of departmental strategic initiatives.
• Enter new therapeutic areas and summarize scientific information from published literature to integrate into new study development.
• Maintain working relationships with team members to ensure scientific integrity of clinical studies.
• Provide advice to others within the company to help resolve moderately complex problems.

Requirements

• PharmD with 2+ years relevant scientific and/or drug development experience, or
• MS with 6+ years relevant scientific and/or drug development experience, or
• BS or RN with 8+ years relevant scientific and/or drug development experience.

Skills

• Excellent verbal and written communication skills
• Strong interpersonal skills