Clinical Research Manager- FSP

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 o