The Senior Clinical Study Manager will be responsible for ensuring the delivery and execution of clinical studies in one or more geographic regions, adhering to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and ICH guidelines. This role involves routine interaction with key internal and external stakeholders to communicate project status, escalate issues, and troubleshoot routine inquiries. The position is primarily a tactical study delivery role, reporting to an Associate Director or above responsible for Operational Study Strategy. The role may require the Sr. CSM to handle both operational strategy and study execution. Key responsibilities include leading the development of the clinical study plan, managing study budgets, overseeing CRO and vendor selection, and ensuring adherence to internal procedures for study planning, conduct, closeout, and reporting.
Hard Skills
- Clinical project management
- Microsoft Project
- CRO and vendor selection
- Protocol and amendment review
- Budget monitoring
Soft Skills
- Expert level written and verbal communication
- Strong decision-making abilities
- Attention to detail
- Leadership
- Risk mitigation
Job Type
This is a contract position with a duration of 6 Month(s).
Work Site
This is a fully remote position.
Work Environment
Candidates local to the NJ area preferred. This is a 100% remote role but candidates should be open to and flexible with face-to-face meetings.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DEI are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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