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.

INDCR