Clinical Research Manager

7 mesi fa

Roma, Italia MSD A tempo pieno

We aspire to be the premier research-intensive biopharmaceutical company in the world. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs, and partnerships. Today, we continue to be at the forefront of research to prevent and treat diseases that threaten people and animals - including cancer, infectious diseases, such as HIV and Ebola, and emerging animal diseases.

Our purpose is to save and improve lives for generations. Our strategy is simple: We follow the science. The path to discovery is often unclear, but we are tireless in seeking solutions for some of the world’s most difficult health challenges.

This role will be key to further develop the country capabilities in **clinical research**, under the direction of the country or cluster CRD/TA-Head the person will be responsible for the end-to-end performance of clinical trials in one or several Therapeutic Areas (TA), from feasibility to close out in one or several countries.

**Responsibilities include, but are not limited to**:

- Lead one or several TA of the growing portfolio in the country;
- Responsible for the successful execution, enrollment and quality of their clinical trial portfolio;
- Ensure performance metrics, timelines and key milestones are met in compliance with ICH/GCP and country regulations, of our policies and procedures, quality standards and adverse event reporting requirements internally and externally;
- Develop operational strategies and quality plans for the conduct of all programs and studies in the TA portfolio;
- Collaborates with other TA directors, local and regional stakeholder in GCTO in order to develop and build territory of principal investigators and sites;
- Ensures oversight and line management of Clinical Research Manager (CRM) team;
- Oversee the performance management and career development of staff and effectively manage performance issues;
- Lead a team independently with supervision from CRD/TAH to high performance;
- Accountable for CRM performance reviews, including addressing low performance situations, and taking appropriate actions;
- Ensures key talent development and retention;
- Collaborates internally with the cross-functional teams on local, regional and global level;
- Collaborates externally with investigators, regulators and vendor;
- Supports strategic initiatives across country, Global Clinical Development GCD and GCTO;
- Supports local strategy development consistent with long-term corporate needs in conjunction with CRD;
- Together with direct reports contributes significantly to effective conduct of clinical studies and to develop the pipeline, while maintaining regulatory requirements and compliance;
- Be the Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT);
- Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out;
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed;
- Performs Quality control visits as required;
- Leads local study teams to high performance: trains in the protocol other local roles;
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies;
- Collaborates internally with the cross-functional teams on local, regional and global level;
- Collaborates externally with investigators, regulators and vendors;
- Supports strategic initiatives across country, Global Clinical Development GCD and GCTO;
- Supports local strategy development consistent with long-term corporate needs in conjunction with CRD.

**Qualifications**

**Education and Minimum Requirements**:

- Bachelor degree in Science (or comparable);
- CRA Experience preferred;
- Advanced degree, (e.g., Master degree, MD, PhD);

**Required Experience and Skills**:

- 10+ years of experience in clinical research with demonstrated success and increasing responsibilities of which 5+ years consisted of leading projects and team;
- Deep understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and execute complex protocols simultaneously;
- Expertise in project and site management: the position requires demonstrated successful implementation of project management skills at program and site level;

**Behavioral Competency Expectations**:

- Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our R&D Division, Global Clinical Development (GCD) and GCTO;
- Experience functioning as a key link between Country Operations and Clinical Trial Teams;
- Communicates effectively and

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