Clinical Operations Manager-F- budgets and contracts – FSP

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…