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Clinical Research Manager
hace 3 meses
Job Description
This role is primarily accountable for the end-to-end performance and project management for
assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting
requirements internally and externally.
The CRM could be responsible for a particular study for several countries in a cluster.
Responsibilities include, but are not limited to:
- 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.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and trainings 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 CTC, CRAs and COM).
- 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.
- 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 the Company with investigators.
- 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, TAH and Regional Operations.
- Collaborates internally with HQ functions, regional and local operations, EU Clinical
- Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.
CORE Competency Expectations:
- Knowledge in Project Management and site management.
- 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 with the support, oversight and supervision of the TA Head or CRD
- Requires strong understanding of local regulatory environment.
- Strong scientific and clinical research knowledge is required.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Experience functioning as a key link between Country Operations and Clinical Trial Teams
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.
- 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.
- Understand cultural diversity.
- The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.
- Behavioural Competency Expectations:
- Strong leadership skills that enable and drive alignment with the goals, purpose and mission of Company Research Labs (MRL), Global Clinical Development (GCD) and GCTO.
- Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
- Required to negotiate skilfully 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.
Experience Requirements:
Required:
• 5-6 years of experience in clinical research
• CRA Experience preferred
Educational Requirements:
Required:
• Bachelor degree in Science (or comparable)
Preferred:
• Advanced degree, (e.g., Master degree, MD, PhD)
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
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:
Project Temps (Fixed Term)Relocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
noJob Posting End Date:
07/24/2024*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.
Job Posting End Date:07/24/2024
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.
Requisition ID:R302330