Study Manager

hace 2 semanas


Madrid, España MSD A tiempo completo

**Job Description**:
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

The goal of GMVC (Global Medical and Value Capabilities) is to drive and innovate world-class Medical & Value Capabilities, to advance research and scientific exchange, improving access and health outcomes for patients as _ONE TEAM_. The **Study Manager** role sits within the Local Data Generation Center Excellence (LDG CoE) in GMVC and in this position, under the supervision of an Associate Director, will lead operational activities related to study planning, study execution and the summarization of results from observational research studies and related activities.

**Study Management Role**
- Coordinate the end to end process for executing observational or non-interventional research studies, in compliance with Good Pharmacoepidemiology Practice (GPP) and CORE Standard Operating Procedures (SOPs). This includes the planning/initiation, execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities (e.g. literature reviews, dossier development, economic modeling support, etc.).
- Collaborate with colleagues across CORE, GMSA and to support the Lead Scientists (from GMSA) in overall operational support for study conduct. Manages several complex activities and study types.
- Main responsibilities involve study level study management support which includes the following activities:

- Facilitation of the execution of appropriate service for approved proposals / scope of work (including the review of requests for information/proposal, draft scope of work, where applicable), confidentiality, and consultant agreements and subsequent amendments/change orders
- Participate in protocol and interiM/Final report preparation and literature review abstraction and summarization
- Coordinate the review and finalization of all vendor documents such as the safety management, data management, communication, project management and validation plans
- Coordinate internal/external meetings and draft/review agenda/minutes
- Track study timelines/deliverables and follow up on action items
- Collaborate extensively and troubleshoot issues by providing potential resolutions, when necessary, with internal and external partners to ensure timely management and execution of studies
- Assist in the tracking of study milestones and timelines
- Assist in managing study level budget which includes forecasting, tracking invoices/spend and communicating with stakeholders such as Portfolio Manager and Finance
- Liaise with outsourced vendors and cross functional teams to communicate and oversee project status and/or needs
- Participate in quality control assessments and ensure integrity of study data for reports and publications
- Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements
- Utilize, manage, and maintain document repositories and internal/external systems
- Ensuring that study work is following current our Research & Development Division and CORE processes and policies
- Provide operational support for due diligence checks, site contract and budget review/approval, informed consent, study registration, IT and/or privacy assessments, vendor qualification, adverse event reporting and reconciliation, and publication submissions.
- Manage poster and publication development including: formatting, medical writing, figure/data content development, co-author review, internal review process, and journal submissions
- Active participation in internal process improvement initiatives or other operational projects (including leading some initiatives) to support LDG CoE leadership and mentoring of other study managers.

**Qualifications**:
**Education**:

- Bachelor's degree required
- Master's degree in Public Health (or closely related discipline, such as health administration or biological sciences) preferred

Preferred:

- PMP or CAPM certification

**Required Experience and Skills**:

- Three to five years of work experience within clinical/observational research or equivalent experience
- Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders
- Basic knowledge of epidemiologic or outcomes research
- Strong project management and prioritization skills
- Highly motivated, able to work independently and collaboratively

Who we are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicine


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