Clinical Research Manager- FSP

• 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

Education:
• Bachelor’s degree in science (or comparable) required; advanced degree (Master’s degree, MD, PhD) preferred

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