Study Manager

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 CORE (Center for Observational and Real-World Evidence) is to generate value evidence, support both regulatory commitments and reimbursement activities and collaborate on the development of market access strategies for our company's products throughout the world. The **Study Manager** (M/F/d) role sits within the Non-Interventional Study Research Operations Center (NIS ROC) of the Strategy & Operations group in CORE 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.

**THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO**:

- 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 modelling support, etc.)
- Collaborate with colleagues across CORE, GMA and to support the Lead Scientists (from GMA) in overall operational support for study conduct
- 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
- 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
- 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 (e.g. VEAP, EngageZone, Veeva Vault and HEART)
- 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

**Requirements**:

- Bachelor's degree required in public health or science discipline. Master's degree in Public Health (or closely related discipline, such as health administration or biological sciences) would be preferred
- PMP or CAPM certification would be preferred
- Minimum of two years experience on study management. Previous roles as Study Coordinator, CRA, CTA, PM in local or global non interventional studies will be considered a strong plus.
- 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
- Fluent in English (written and spoken)
- Strong project management and prioritization skills
- Highly motivated, able to work independently and collaboratively

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Weystrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location ha