Associate Clinical Research Manager (aCRM) - Infectious Disease (REMOTE)
USA - New Jersey - Rahway
Job Description
With support of other CRMs and/or TA-Head/CRD, this role is 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 policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The aCRM could be responsible for a particular study for a country or 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 policies and procedures, quality standards and adverse event reporting requirements internally and externally.
o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.
o 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.
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
As a customer-facing role, this position will build business relationships and represent our Company with investigators.
Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TA-Head and Regional Operations.
Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific 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
Skills:
Knowledge in Project Management and/or site management.
Strong organizational skills with demonstrated success in related role or discipline required.
Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments …
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Hybrid Hybrid work Hybrid work model
Benefits/PerksBonus eligibility Diverse workplace Flexible work arrangements Hybrid work Hybrid work model Inclusive environment Insurance Meetings Paid holidays Retirement benefits Separation benefits package Sick Days Vacation
Tasks- Build business relationships
- Collaborate with external partners
- Collaboration
- Communication
- Compliance
- Conflict resolution
- Ensure compliance with regulations
- Feasibility
- Innovation
- Leadership
- Planning
- Project management
- Quality control
- Reporting
- Risk Management
- Strategy development
Business Operations Clinical Clinical Development Clinical Research Collaboration Commercial Communication Compliance Conflict Resolution CTMS Diversity English Proficiency Execution GCP ICH Inclusion Innovation Leadership Management Manufacturing Metrics Monitoring Organizational Pharmacovigilance Planning Project delivery Project Management Qualification Quality Quality Control Quality Standards Recruitment Regulatory Regulatory Affairs Regulatory Compliance Reporting Research Risk Management Site Management Strategic Thinking Strategy Strategy Development Talent Acquisition Training
Experience3 years
EducationBachelor 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