**Seeking an Experienced Clinical Research Project Manager**

The Sr. Regional PM leads the study team and has strategic oversight of the study at a US level as well as operates within the day to day management of the trial at the same time. They are supported by an Operational Lead As an Sr. Regional PM, the candidate has the overall responsibility of the study commitments for the US based sites aligned with a global trial. They work closely with the global team who has all encompassing study oversight internationally.

• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
• Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
• Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in clinical studies financial system by regular checks of the system and financial reports
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Communicates and co-ordinates regularly with National Coordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
• Collaborates with local Medical Affairs team.
• Supports SMM in different initiatives (local, regional or global) as agreed with the CH/CD SMM.

Minimum Requirements (MUST HAVE)

• 5+years of Hands On project oversight (similar to in-house oversight) - This cannot be strictly CRO oversight at a Pharma. Qualified candidates will have experience overseeing a study hands on.
• 2+ years of budget build out experience and negotiations. (this refers to the overall budget for the study not just CRA travel for instance).
• 4 year bachelor's degree in related field

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.