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When our values align, there's no limit to what we can achieve.
At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP is looking for a Clinical Research Manager!
Job Purpose:
The Clinical Research Manager (CRM) is responsible for the following:
Primarily accountable for end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
For certain studies, could be responsible for several countries in a cluster.
Supporting Activities- May include but not limited to the following:
Study Management
Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT)
Responsible for project management of the assigned studies:
o Proactively plans/drives/tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and closeout Accountable for performance for assigned protocols in country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally o Performs quality control visits as required.
o Reviews Monitoring Visits Reports (MVRs) and escalates performance issues and training needs to Clinical Research Associate Manager and /or functional vendor and internal management as needed
Leads local study teams to high performance:
o Trains in the protocol for other local roles. o Collaborates with and supports Clinical Research Associates as protocol expert. o Coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinator (CTC),
Clinical Research Associates (CRAs), and Clinical Operations Manager (COM)
Responsible for creating and executing a local risk management plan for assigned studies
Ensures compliance with Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies
Escalates as needed different challenges and issues to Therapeutic Area (TA) Director / Clinical Research Director (CRD) / Clinical Quality Management (CQM) 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 Point of Contact for programmatically outsourced trials for assigned protocols
As a customer-facing role, this position will build business relationships and represent Client 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, TA Head and Regional Operations
Team development and support
Leads and contribute to initiatives and projects adding value to the business and supporting the strategy
Compliance with Parexel standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and complies with Parexel processes,
ICH-GCPs and other applicable requirements
Skills:
Strong organizational skills with demonstrated success required
Requires ability to make decisions independently while overseeing important activities relevant to clinical research in the country according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Director or CRD
Requires strong understanding of the local regulatory environment
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
Strategic thinking
Ability to work efficiently in a remote and virtual environment.
Strong leadership skills that enable and drive alignment with the goals, purpose and mission of Client, Global Clinical Development (GCD) and Global Clinical Trial Operations (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. Examples of common problems include low patient recruitment; inadequate staff to meet business needs; performance or compliance issues; working with regulatory issues and the broader organization; and resolution of conflictive situations
Understands cultural diversity
Proficiency in written and spoken English and local language; must be competent and effective in written and verbal communication
Education/pedagogic, diplomatic, and empathetic skills to effectively build and maintain professional relationships with investigators and other external stakeholders
Travel expectations is up to 30% of working time
Knowledge and Experience:
5-6 years of experience in clinical research; CRA experience preferred.
Knowledge in Project Management/Site Management with proven strong project management skills and /or project management certification or relevant training program/close mentoring
Strong scientific and clinical research knowledge is required with strong understanding of clinical trial planning, management, and metrics as well as the ability to focus on multiple deliverables and protocols simultaneously
Experience functioning as a key link between CO and CTT
