Clinical Research Manager - General Medicine (REMOTE)
USA - New Jersey - Rahway
Job Description
Position Description:
Clinical Research Manager - General Medicine (REMOTE)
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, Our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The Clinical Research Manager (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, 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.
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 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 Human Health as needed.
Extent of Travel: Up to 30% of working time
CORE Competency Expectations:
Knowledge in Project Management and site …
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Hybrid Hybrid work model
Benefits/PerksFlexible hours Flexible work arrangements Hybrid work Hybrid work model Inclusive environment Insurance Meetings Mentoring Paid holidays Professional development Remote work Retirement benefits Sick Days Vacation
Tasks- Build business relationships
- Collaborate with teams
- Collaboration
- Communication
- Compliance
- Conflict resolution
- Ensure compliance
- Innovation
- Leadership
- Mentoring
- Planning
- Project management
- Quality control
- Reporting
- Risk Management
Business Operations Clinical Clinical Development Clinical Research Clinical trials Collaboration Commercial Communication Compliance Conflict Resolution CRM CTMS GCP ICH Innovation Leadership Management Manufacturing Medical Affairs Mentoring Metrics Organizational Planning Project Management Quality Quality Control Quality Standards Recruitment Regulatory Reporting Research Risk Management Scientific Knowledge Site Management Strategic Thinking Strategy Development Training
Experience5 years
EducationAdvanced degree Bachelor degree Business Management Science
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9