Senior Manager of Clinical Study Lead - Contract - Basking Ridge NJ
Proclinical is seeking a Senior Manager, Clinical Study Lead to oversee and manage clinical study operations.
Primary Responsibilities :
This role focuses on developing study-specific documentation, ensuring compliance, managing budgets and timelines, and leading risk assessments.
The successful candidate will also be responsible for site selection, patient recruitment strategies, and ensuring data quality throughout the study lifecycle.
Skills & Requirements :
- Bachelor's degree in a relevant field along with 8+ years of relevant industry experience.
- Proven experience managing global clinical trial operations including developing protocols and key study documents
- Have demonstrated results building and developing outstanding teams
- Be able to understand and implement strategic direction and guidance to the team
- Proficiency in trial management software and MS applications
- Good organisational and communication skills
- Ability to directly supervise the Clinical Trial Management staff
The Senior Manager's responsibilities will be :
- Develop and manage study-specific documentation
- Supervise the setup and maintenance of study systems (e.g., CTMS, TMF).
- Ensure compliance with clinical trial registry requirements.
- Manage study budgets, timelines, and results.
- Lead risk assessments and develop mitigation strategies.
- Conduct feasibility assessments and select study regions and countries.
- Oversee site evaluation, selection, and investigator meetings.
- Monitor site activation and visits, addressing any deviations.
- Develop and implement patient recruitment and retention strategies.
- Oversee study drug and clinical supplies forecasting and accountability.
- Ensure data quality through regular review of metrics and listings.
- Maintain audit and inspection readiness throughout the study lifecycle.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at [email protected]
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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