Job Description
Associate Director- Clinical Research
This role will be key to further develop the country capabilities in clinical research. Under the direction of the country or cluster CRD/TA-Head the person will be responsible for the end-to-end performance of clinical trials in 1 or several Therapeutic Areas (TA), from feasibility to close out in 1 or several countries. The role will be responsible for oversight of the employees working in the TA, with line management of CRMs and functional oversights of other roles in their studies. At the discretion of the CRD/TAHead, the role could also be responsible for direct project work and will ensure excellent study performance with strict adherence to local regulations, our company SOPs and ICH GCP.
As line manager the role is critical to develop key talents in the organization to ensure a pool of successors in critical roles. The role will work at country level with other local stakeholder like GMA, GHH, PV and regulatory to ensure alignment and development of the country capabilities and collaborates and works closely with other stakeholders in the TA in GCTO & GCD.
Responsibilities include, but are not limited to:
• Will lead 1 or several TA of the growing portfolio in the country.
• Accountable for the successful execution, enrollment and quality of their clinical trial portfolio
• Accountable to ensure performance metrics, timelines and key milestones are met in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Accountable to develop operational strategies and quality plans for the conduct of all programs and studies in the TA portfolio.
• Collaborates with other TA directors, local and regional stakeholder in GCTO in order to develop and build territory of principal investigators and sites.
Ensures oversight and line management of Clinical Research Manager (CRM) team.
• Oversee the performance management and career development of staff and effectively manage performance issues.
• Lead a team independently with supervision from CRD/TAH to high performance.
• Accountable for CRM performance reviews, including addressing low performance situations, and taking appropriate actions.
• Ensures key talent development and retention.
• Collaborates internally with the cross-functional teams on local, regional and global level.
• Collaborates externally with investigators, regulators and vendors
• Supports strategic initiatives across country, Global Clinical Development GCD and GCTO
• Supports local strategy development consistent with long-term corporate needs in conjunction with CRD.
• Together with direct reports contributes significantly to effective conduct of clinical studies and to develop the pipeline, while maintaining regulatory requirements and compliance
• Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed. Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA-Head/CRD/CCQM and or CTT(as appropriate).
• Identifies and shares best practices across clinical trials, countries, clusters.
• May act as a mentor.
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent our company with investigators and medical centers.
• Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
• Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TA-Head and Regional Operations
Qualifications, Skills & Experience:
Skills:
• Expertise in project and site management. The position requires demonstrated successful implementation of project management skills at program and site level.
• Strong organizational skills with demonstrated success required.
• Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments
• Requires a complete understanding of ICH GCP and global/regional/local regulatory environment.
• Strong scientific and clinical research knowledge is required. Including extensive knowledge of regional and/or country clinical trial landscape.
• Deep understanding of our Research & Development Division organizational structure and cross-functional roles and responsibilities of its members.
• Strong understanding of clinical trial planning, management and metrics is essential as well as
the ability to focus on multiple deliverables and execute complex protocols simultaneously.
• Experience functioning as a key link between Country Operations and Clinical Trial Teams.
• Communicates effectively and fosters a collaborative spirit in a remote/virtual environment and across countries, cultures and functions.
• Ability, experience, and skills to proactively manage resource allocation, processes (and controls), productivity, quality and project and/or program delivery.
• Oversee TA strategy alignment and consolidate relevant information, within specific indications, escalating to the TA-H / CRD accordingly.
• Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking.
• Ability to work efficiently in a remote and virtual environment.
• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring. High emotional intelligence
• Ability to focus on multiple deliverables and protocols/projects simultaneously.
• Exercise strategic thinking and executes effectively across projects.
• Fosters understanding of cultural diversity.
• Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our company Research Labs ( our Research & Development Division ), Global Clinical Development (GCD) and GCTO.
• Ability to identify problems, conflicts and opportunities early and lead, analyze and creatively 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 disruption.
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.
• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.
Qualification & Experience:
Required:
• 10+ years of experience in clinical research with demonstrated success
and increasing responsibilities of which 5+ years consisted of leading projects and team
• Bachelor's degree in science (or comparable)
Preferred:
• CRA Experience preferred
• Advanced degree, (e.g., Master degree, MD, PhD)
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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.
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.
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
اطلب مساعدة الخبراء لكتابة سيرة ذاتية مميزة.