This role if for COM-F
Job Purpose:
The Clinical Operations Manager (COM)/ Clinical Operations Manager Finance (COM-F)/ Clinical Operations Manager Regulatory (COM-R) is responsible for the following:
Performance and compliance 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.
Budget/finance aspects, for execution and oversight of clinical trial country submissions and
approvals and to ensure Site Ready under the oversight of the Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD).
This position has significant impact on the delivery of country specific trial commitments and objectives especially during study start-up.
Key Accountabilities:
Study Management
Manages country deliverables, timelines, and results for assigned protocols
to meet country commitments including quality and compliance in assigned
protocols in country
Oversees Clinical Trial Coordinators as applicable
Coordinates and liaises with Clinical Research Managers (CRMs), Clinical
Research Associates (CRAs) and Clinical Trial Coordinators (CTCs),
Finance and Legal if appropriate to ensure country deliverables are obtained
for submissions, budgets, Clinical Trial Research Agreements (CTRAs) and
local milestones
Collaborates closely with Headquarter to align country timelines for assigned
protocols
Provides support and oversight to local vendors as applicable
Oversees and coordinates local processes, clinical and ancillary supplies,
import and export requirements, supplies destruction, local electronic/hard
copy filing, archiving and retention requirements, and insurance process
management. Enters and updates country information in clinical and finance
systems
Delivers clinical and financial contracts within fair market value through
continual interaction with local clinical teams
Works in partnership internally with Global Clinical Trial Organization
(GCTO) country operations, finance, regulatory affairs, pharmacovigilance,
legal and regional operations, Headquarter (HQ) functional areas and
externally with vendors and sites, Internal Review Board (IRB) / Independent
Ethics Committee (IEC) and Regulatory Authorities in submission and
approval related interactions
Finance Management (as applicable)
Has ownership of country and site budgets including development,
negotiation, and completion of Clinical Trial Research Agreements (CTRA)
Oversees and tracks clinical research-related payments and payment
reconciliation at study close-out
Oversees Foreign Corrupt Practices Act (FCPA), Denied Party
Screening/Office of Foreign Assets Control (DPS/OFAC) and maintenance
of financial systems and financial forecasting in conjunction with Senior
Clinical Operations Manager, Clinical Research Director and other roles
Influences investigators, external partners, and country operations to adhere
to budget targets and agreed payment timelines
Regulatory Management (as applicable)
Executes and oversees clinical trial country submissions and approvals for
assigned protocols
Develops local language materials including local language Informed
Consents and translations
Interacts with IRB/ IEC and Regulatory Authority for assigned protocols
Team development and support
Contributes or leads initiatives and projects adding value to the business.
Contributes strongly to the Clinical Operations Manager team and other
Country Operations roles knowledge by acting as process Subject Matter
Expert (SME), sharing best practices, making recommendations for
continuous improvement and providing training as appropriate/required.
Contributes to Clinical Operations Manager team knowledge by acting as a
buddy/mentor and sharing best practices as appropriate/required
Compliance with Parexel standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintain a working knowledge of and comply with Parexel processes, ICH-
GCPs and other applicable requirements
Skills:
Strong coordination and organizational skills.
Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up
Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager
Ability to make decisions independently with limited oversight from SCOM or manager.
Requires a strong understanding of local regulatory environment
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally
Ability to lead a team of CTCs as applicable
Problem solving is essential. Requires ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate to management as applicable.
Examples include:
Issues in budget/CTRA negotiation
o Quality and compliances issues
o Regulatory and legal issues
o Issues related to functional area deliverables that could jeopardize protocol milestones
Effective and efficient time management, organizational and interpersonal
skills, and conflict management skills
High sense of accountability and urgency to prioritize deliverables
Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills
Ability to focus on multiple deliverables and protocols simultaneously
Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people
Positive mindset, growth mindset, capable of working independently and self - driven.
Ability to directly influence site staff
Excellent verbal and written influencing and training/mentoring skills, in local language and English
Minimal travel required.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
