Project Manager

5 months ago

Bangalore, India MUM Fortrea Development India Pvt Ltd Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

On the Client level: 
• FINANCIAL (as applicable): 
o Ownership of country and site budgets. 
o Development, negotiation, and execution of Clinical Trial Research Agreements 
(CTRA)

Through continual interaction with local clinical team/s successfully delivers clinical 
and financial contracts within fair market value. 
o Oversight and tracking of clinical research-related payments.
o Payment reconciliation at study close-out. 
o Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. 
o Financial forecasting and tracking of operational budget in conjunction with the 
client manager. 
• COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable): 
o Responsible for execution and oversight of clinical trial country submissions and 
approvals for assigned protocols. 
o Development of local language materials including local language Informed 
Consents and translations. 
o Works in partnership with IRB/IEC and Regulatory Authority in submission and 
approval related interactions for assigned protocols. 
o Deliver expertise in country-based regulations, laws, and procedures. 
o Provide an oversight and tracking of clinical research-related payments. 
o Overlook payment reconciliation at study close-out. 
• MANAGEMENT & QUALITY OVERSIGHT: 
o Responsible for managing country deliverables, timelines, and results for assigned 
protocols to meet country commitments. 
o Contributes to the development of local SOPs.
o May oversee contract workers and local vendors as applicable. 
• COLLABORATION: 
o Works in close collaboration internally with Clinical country operations (CRD, CRM,
CTC, CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory 
Affairs, Pharmacovigilance, Business Compliance, Legal and regional operations, 
Head Quarter functional areas and externally with vendors and sites, IRB/IECs and 
Regulatory Authorities to ensure country deliverables are obtained for submissions, 
budgets, CTRAs and local milestones. 
o Collaborates closely with Regional Operations to align country timelines for assigned 
protocols. Provides support and oversight to local vendors as applicable

LOCAL PROCESS OVERSIGHT: (as applicable): 
o Oversight and coordination of local processes & SOPs.
o Responsible for clinical and ancillary supplies management, importing and exporting 
requirements, supplies destruction, local electronic/hard copy filing, archiving and 
retention requirements, and insurance process management. 
o Enters and updates country information in clinical, regulatory, safety and finance 
systems. 
• And all other duties as needed or assigned
 

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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