Clinical Program Lead - REMOTE

Proclinical is currently recruiting for a Clinical Program Lead with a global biopharmaceutical company located remotely and in Boston, MA. As the Clinical Program Lead, you will be responsible for and manage study deliverables through internal and external resources and is the primary point of contact and interface between these functional groups, investigator sites and vendors.

Job Responsibilities:

• Direct the creation and execution of clinical trial activities.
• Ensure compliance of clinical trials with national and international regulatory requirements; overall data quality and integrity; and human subject protection.
• Builds and leads cross functional clinical study team to achieve study milestones
• Interact with internal and external groups to achieve study milestones.
• Determine study requirements, define specifications, and initiate and lead vendors.
• Manage CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon time, budget and quality.
• Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report.
• Provides input into the clinical development strategy for assigned programs; including but not limited to, operational feasibility, budget and timeline estimates.

• Set program level standards and best practices to ensure consistent execution and delivery across studies.
• Participate in and/or lead departmental initiatives.
• Conduct lessons learned exercises to provide continuous process improvement and sharing of best practice.
• Execute the project management process and the deliverables linked to this process. This includes planning, directing and coordination, organizing, staffing, and controlling related to the project management process.
• Manage the operational components of the clinical study in its entirety including planning, resourcing, timelines, quality control, and financial management.
• Report project information to the applicable stakeholders (e.g. data management, program managers).

Skills and Requirements:

• Minimum requirement: Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
• Strong project management and communication.
• Experience in Expanded Access programs preferred.
• Advanced degree is desirable.
• PMP certification desirable.

If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181 or m.jacobs@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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