Study Delivery Manager – EEMEA CoE
  • Merck
  • 28/04/2023
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Job DescriptionStudy Delivery Manager will be responsible for efficient delivery of Medical Affairs observational studies (LDGs) and for coordination/follow-up for our Company-funded Investigator Initiated Studies (IISs) across all Therapy Areas in EEMEA region, ensuring quality and compliance. Key ResponsibilitiesCoordinating and managing the operational work that is required for the timely delivery of observational studies including but not limited to study start up, study execution and reporting through Contract Research Organizations (CROs):Partner with Regional Procurement for identifying, screening, qualification and contracting of CROsBe the operational point of contact for CROsProvide oversight to these vendors and ensure delivery of services as per agreed upon performance metricsPerform periodic quality checks and on-site accompanied quality visits to ensure that vendors adhere to GPP, latest SOPs, ERs, standards, and systemsSupport country teams in audit preparations related to observational studies.Keeping an overview of output and progress of the observational studies, proactively identifying and resolving issues to complete the studies within time, budget and quality requirementsEnsure proper tracking of the observational studies portfolio across EEMEA regionKeep our internal study tracking systems up to dateEnsure proper and timely archival of related study documents in the internal systems as per SOPsFor all the Investigator Initiated Studies (IISs) that have been approved for funding, coordinate with investigators, MISP-RC office and country medical teams for contracting, quarterly follow-up reports, milestone payments and end of study processes in a timely and effective mannerRequired Qualification & ExperienceBachelor’s / Master’s degree in Life Sciences or related studiesMinimum of four years of pharmaceutical/biotechnology/medical device industry experience in study execution either in clinical operations and/or in medical affairs functionKey Competencies RequiredClinical research operational managementStakeholder management & working across boundariesProject management & problem solvingProcess & systems managementCross-functional collaborationWho 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 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 … Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.Current Employees apply Current Contingent Workers apply Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Shift:Valid Driving License:Hazardous Material(s):

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