Clinical Research Manager (Remote Based)
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck 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. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’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.
The CRM has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent Merck with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.
The position requires the ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
Primary activities/responsibilities include but are not limited to:
- The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- The CRM is the country point of contact (POC) for assigned protocols and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles.
- The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
- The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols.
- The CRM is responsible for clinical trial education to sites.
- The ability to identify problems, conflicts and opportunities early and lead, analyses and prepare mitigation plans and drive conflict resolution is critical. The position requires skilful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing.
- Bachelor’s degree or equivalent with 8+ years of experience in Clinical Research, OR a Master’s degree with 6+ years of experience in clinical research, OR a PhD/MD with 3+ years of clinical research experience
- Strong communication, diplomatic and empathic skills
- Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance
- Strong organizational skills with demonstrated success required
- Excellent oral and written English language skills
- Problem solving and conflict resolution
- Negotiation skills with both internal and external groups
- Project Management experience
- Experience with managing clinical trials within a country from site selection to site close out.
- Experience working in a matrix environment.
- Experience in Infectious Disease studies.
Your role at Merck 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 Merck, we’re inventing for life.
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Job: Clinical Research Monitor(CRA)
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck