Clinical Research Manager
Clinical Research Manager
Intellectt Inc
East Hanover, NJ
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Role: Clinical Research Manager
Location: East Hanover, NJ
Duration: Long Term
Description
Must have : Pharma background is must, clinical research experience, drug development experience, GCP
The Clinical Development Director is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), and/ or indication related clinical trial(s), under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase)
Responsibilities
Location: East Hanover, NJ
Duration: Long Term
Description
Must have : Pharma background is must, clinical research experience, drug development experience, GCP
The Clinical Development Director is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), and/ or indication related clinical trial(s), under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase)
Responsibilities
- Lead clinical deliverables in projects/programs, including protocol and regulatory document development.
- Drive clinical sections in regulatory submissions and manage program execution with global teams.
- Oversee safety aspects of the molecule, contribute to safety reporting, and support Therapeutic Area Head with medical inputs.
- Collaborate in pre-PoC projects and business development activities.
- Facilitate career development and training of clinical colleagues and participate in global clinical initiatives.
- Timely, high-quality clinical deliverables.
- Effective clinical research methodology implementation.
- Quality contributions to regulatory documents and stakeholder acceptance.
- Advanced life sciences/healthcare degree (PharmD or PhD preferred).
- Fluent in English.
- 7+ years in clinical research/drug development, including global trial experience.
- Knowledge of assigned therapeutic areas and GCP.
- Strong in scientific partnerships, communication, and people management.
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Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Research, Analyst, and Information Technology -
Industries
Staffing and Recruiting
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