What are the responsibilities and job description for the Senior Clinical Study Lead position at Proclinical Staffing?
Senior Clinical Study Lead - Contract - Basking Ridge, NJ
Proclinical is seeking a dedicated Clinical Study Lead for a Senior position to oversee the global execution of large and complex clinical trials.
Primary Responsibilities:
This role involves ensuring compliance with standard operating procedures and regulatory guidelines. The successful candidate will lead cross-functional teams and drive process improvement initiatives. This position requires onsite presence for at least three days a week.
Skills & Requirements:
- Strategic understanding and implementation abilities.
- Data-driven and problem-solving approach.
- Effective communication and negotiation skills.
- Experience in budget management and vendor management.
- Proficiency in trial management systems and MS applications.
- History of working with ICH/GCP and regulatory guidelines.
- Project management and organizational skills.
- Experience in global clinical trial operations and protocol development.
- Ability to build productive teams and collaborations.
The Senior Clinical Study Lead's responsibilities will be:
- Head up cross-functional study teams for clinical study delivery.
- Oversee development of study-specific documentation.
- Manage study systems setup and maintenance.
- Ensure compliance with clinical trial registry requirements.
- Identify outsourcing needs and manage vendor engagements.
- Contribute to budget and timeline development and management.
- Lead risk assessment and mitigation strategies.
- Prepare and execute investigator meetings.
- Monitor site activation and patient recruitment strategies.
- Ensure accurate budget management and scope changes.
- Oversee study drug and clinical supplies management.
- Ensure audit and inspection readiness throughout the study lifecycle.
- Manage study close-out activities and contribute to report writing.
- Support process improvement initiatives and innovative approaches.
If you are having difficulty in applying or if you have any questions, please contact Bo Forsen at b.forsen@proclinical.com
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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