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Clinical Research Manager - Boise, United States - Idaho State Job Bank
Description
Clinical Research Manager - Oncology (Remote) at Merck in Boise, Idaho,United States Job Description Job Description Position Description:
Clinical Research Manager
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).
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, Our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
+ 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.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 our 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, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials.
Consult with GHH as needed.Extent of Travel:
+ Up to 30% of working time 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.
Position Qualifications :
Education Minimum Requirement:
+ Required: Bachelor degree in Science (or comparable) + Preferred: Advanced degree, (e.g., Master degree, MD, PhD)
Required Experience and Skills:
+ Required: Minimum 5 years of experience in clinical research
Behavioral Competency Expectations:
+ Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our Company'sResearch&DevelopmentDivision , Global Clinical Development (GCD) and GCTO. + 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 disruption.
Preferred Experience and Skills:
+ Oncology experience preferred + CRA Experience preferred MRLGCTO #EligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy