Clinical Research Manager ?stanbul Job Description
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy. MSD's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. It is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Our research labs are a true scientific research facility of tomorrow and will take our company's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Your role at our company is integral to helping the world meet new breakthroughs... that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we're inventing for life .
Responsibilities include, but are not limited to: Accountable for performance and compliance 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. POC for assigned protocols between ROC and CO. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols. Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.
Requirements: Bachelor's degree minimum, master's in science (or comparable) preferred. Advanced degree (MD, PhD) possible but not required. 8-10 years of experience in clinical research. Clinical research experience essential. People management experience possible but not required. Strong leadership skills. Knowledge in Site Management. Position requires excellent oral and written English language skills. Strong organizational skills with demonstrated success required. Oversees contractors/outsourced functions, provides oversight of contract workers (CRAs, CTC) and works closely with external vendors, site investigators.
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.
Flexible Work Arrangements:
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Number of Openings:
1 ?stanbul Turkey
Clinical Research Manager ?stanbul Merck & Co., Inc. ?stanbul