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 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 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.
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, GMA and to support the Lead Scientists (from GMA) 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 NIS ROC 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
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 has a target date of 2021 for operational readiness.
We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.
The recently opened new location in Zurich focuses on accelerating research, data and commercialization of our medicines and vaccines. The new office will be staffed by teams working in strategic and operational roles in medical affairs, clinical development, access and marketing operations functions.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, 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 medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
Invent. Impact. Inspire.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
InternationalVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID:R92161