Clinical Research Manager

2 settimane fa

Lazio, 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.
The roles of ACRM (Associate Clinical Research Manager) and CRM (Clinical Research Manager) are primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
**Responsibilities include, but are not limited to**:
- Main Point of Contact (POC) for assigned protocols and the 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.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- 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 of other local roles, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).
- Responsible for creating and executing a local risk management plan for assigned studies.
- Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.
- Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).
- Identifies and shares best practices across clinical trials, countries, and clusters.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
- Country POC for programmatically outsourced trials for assigned protocols.
- As a customer-facing role, this position will build business relationships and represent our company with investigators.
- Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
- Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH, and Regional Operations.
- Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, and Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.
**Qualifications**
**Education and Minimum Requirements**:
- Bachelor's or advanced degree in science with some years of relevant work experience in clinical research.
**Required Experience and Skills**:
- Knowledge in Project Management and site management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD
- Requires a strong understanding of the local regulatory environment.
- Strong scientific and clinical research knowledge is required.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Experience functioning as a key link between Country Operations and Clinical Trial Teams
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.
- Proficiency in written and spoken English and Italian. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking.
- Ability to work efficiently in a remote and virtual environment.
- Understand cultural diversity.
- The position requires proven stron

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