MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
PERFORMANCE & COMPLIANCE
Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, MSD 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.
EXTERNAL CUSTOMER FACING
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.
INTERNAL COLLABORATION & STRATEGY
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.
Significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. The position 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 MSD with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.
Requires 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.
The ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical. Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be both direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations on country level.
Strong scientific and clinical research knowledge is required for this position. A strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. Requires skills to effectively build and maintain professional relationships with investigators and other external stakeholders, requiring strong communication, educational/pedagogic, diplomatic and empathic skills. The role will require proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment.
The position requires strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance. Oversee country commitments, compliance and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously.
Works collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors. Requires coordination and alignment with the regional and broader organization. Additionally, will work to build and maintain relationships with investigators and other external partners and promote MSD's reputation. In collaboration with CRD, represents MSD in Pharma industry issues and in seeking influence in external R&D environment
Bachelor's degree minimum, Master 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.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Job: Clinical Research Generic Job Title:Assoc. Dir, Clinical Research
Primary Location: EMEA-Turkey-Istanbul-Istanbul
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Clinic, Medical, Medical Research, Clinical Research, Healthcare, Research