ICON Strategic Solutions · 4 hours ago

Senior Site Contract Analyst

United States

Contract

Remote

Senior Level

5+ years exp

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Pharmaceutical Manufacturing

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Responsibilities

Develop site-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), or other related contractual documents (collectively, the “contractual documents”)

Negotiate contractual documents using the established negotiation and escalation plan

Track the progress and status of contractual negotiations and prepare appropriate status reports as required

Facilitate the execution of contractual documents between the investigator, site, and Sponsor

Serve as a mentor to new or junior staff, providing required project specific training and addressing project questions/issues

Work collaboratively with study team to set up and maintain contract management systems that facilitate the creation, distribution, negotiation, and execution of contractual documents

Serve as the primary point of contact and escalation for investigator sites, the global negotiation network, or study team members (e.g. CRAs) during the negotiation of the contractual documents

Assist with preparation of performance metrics (i.e. median cycle times)

Notify management, as appropriate, of any out-of-scope requests or activities, timeline changes, or resource constraints

Qualification

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Contract ManagementClinical Trial AgreementsConfidential Disclosure AgreementsClient Service ExperienceStudy Start-Up ExperienceElectronic Document ManagementPerformance Metrics PreparationProject Management

Required

B.A./B.S. preferably in a business or science/health care field, nursing degree, or equivalent degree

Five (5) years of prior experience in a client service role at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research in a contract management capacity

Prior Study Start-Up experience at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities

Preferred

Prior experience in working with electronic document management system(s) or similar portal environment desired

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs

Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead

Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others