Job Description

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 [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.

INDCR

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