Clinical Research Manager (NY/NJ) (FullTime)

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To manage protocols EOP1008, EOP1010, and EOP1011.

Clinical Study Design:

Supports the authoring of the clinical content of Protocols/Protocol Amendments. Approves Case Report Forms. Approves CRF Review Manual. Oversees the development and execution of investigator contracts. Manages/Oversees study start-up documents including investigator study files, enrollment logs, etc. Plans and prepares Investigator Meetings. Develop patient recruitment strategy.

Clinical Study Execution:

Provides clinical-related progress of project schedule/timelines and budget. Manages day-to-day interactions with Regional Monitors. Prepares and presents at Investigator Meetings, training sessions, and internal meetings. Tracks and reports patient recruitment and retention at investigational sites. Proactively identifies study-related issues and provides recommendations for resolution to Clinical team.

Clinical Study Reporting:

Supports the authoring of clinical portions of Clinical Study Reports and annual reports. Assists in preparation of NDAs. Assist in selecting CRO and outside vendors.

Job Competencies:

Demonstrates expert knowledge of the clinical study process, GCP/ICII guidelines and SOPs. Develops knowledge of therapeutic area through experience and review of scientific literature. Demonstrates analytical thinking, concern for standards, concern for impact, good team skills (including cooperation) willingness to learn from others, sharing of relevant information, adaptability, self-control, tenacity, and conflict-resolution skills. Demonstrates computer proficiency and has the ability to develop advanced computer skills to increase efficiency in day-to-day tasks. Excellent organization and time management skills, detailed-oriented, ability to multitask in a high-volume environment. Prepare and present at internal and external meetings. Plan, coordinate, and facilitate internal and external meetings. Demonstrates professionalism and mutual respect.

Qualifications

• Bachelor’s degree in biological science or healthcare-related field or licensed registered nurse.
• Graduate Degree preferred.
• Five to eight years of relevant experience in industry (strongly preferred), or healthcare-related field, or equivalent overall experience in combination with exceptional performance.
• Good oral and written communication skills.
• Detail-oriented.
• Demonstrated ability to work in a team environment, as well as independently.