(Associate) Project Manager Start-up

Job Overview:
Accountable for execution and oversight of local operational clinical trial activities and hasownership oversight and impact on local regulatory and financial compliance at a countryoperations level at the client. The position has a significant impact on how a country can delivercountry-specific trial commitments and objectives especially during study start-up. The ability toindirectly influence investigators vendors external partners and country managers to deliver thesecommitments is a must. This includes adhering to budget targets and agreed payment timelinesaddressing and resolving issues maintaining expertise in country-based regulations laws andprocedures with minimal support from the client management. Requires skilled knowledge ofbudget and contract negotiations the local ethics legislation and regulatory environmentsubmission and approval processes development of local Informed Consent as well as other siteready and ongoing study deliverables. Ability to proactively develop risk management andmitigation plans in the country and resolve issues locally.

Summary of Responsibilities:
FINANCIAL (as applicable):
o Assistance with the ownership of country and site budgets.
o Through continual interaction with local clinical team/ssuccessfully delivers clinicaland financial contracts within fair market value.
o Oversight and tracking of clinical research-related payments.
o Payment reconciliation at study close-out.

COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable):
o Responsible for execution and oversight of clinical trial country submissions andapprovals 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 andapproval related interactions for assigned protocols.

MANAGEMENT & QUALITY OVERSIGHT:
o Responsible for managing country deliverables timelines and results for assignedprotocols to meet country commitments.
o Contributes to the development of local SOPs.

COLLABORATION:
o Works in close collaboration internally with Clinical country operations (CRD CRMCTC CRA) Country Quality Manager (CQM) Finance Medical Affairs RegulatoryAffairs Pharmacovigilance Business Compliance Legal and regional operationsHead Quarter functional areas and externally with vendors and sites IRB/IECs andRegulatory Authorities to ensure country deliverables are obtained for submissionsbudgets CTRAs and local milestones.
o Collaborates closely with Regional Operations to align country timelines for assignedprotocols. Provides support and oversight to local vendors as applicable.

LOCAL PROCESS OVERSIGHT: (as applicable):
o Responsible for clinical and ancillary supplies management importing and exportingrequirements supplies destruction local electronic/hard copy filing archiving andretention requirements and insurance process management.
o Enters and updates country information in clinical regulatory safety and financesystems.
And all other duties as needed or assigned.

Qualifications(Minimum Required):
University/college degree (life science preferred) or certification in a related allied healthprofession from an appropriately accredited institution nursing certification medical orlaboratory technology.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
In lieu of the above requirement candidates with a minimum of four (4) or more years ofrelevant clinical research experience in pharmaceutical or CRO industries or experience in ahealth care setting will be considered.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatoryrequirements in other countries
Thorough understanding of the drug development process
Fluent in Dutch and in English both written and verbal.

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