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Clinical Contracts Associate
4 months ago
Description:
* Manage end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, escalation, translation, distribution, signature, archiving).
* Support site-related questions regarding invoice preparation with respect to submission of invoices
* Support resolution of contract and budget issues
* Support contracting with local vendors
* Maintain contract tracking in appropriate systems
* Manage Confidential Disclosure Agreement process
* Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness
* Ensure payments are made in accordance with contracts
* Maintain payment data tracking in appropriate systems
* Responsible for providing information for entry into systems
* Negotiate site contracts from the contract templates using appropriate guidelines, and collect necessary signatures for contract execution
* Negotiate site budgets from base budget and payment milestones using appropriate guidelines; complete final budget for inclusion in the contract
* Escalate contract and budget issues to Legal or Clinical Pricing & Payments Group and GCPM as appropriate to ensure Fair Market Value compliance
* Set up financial data, raise purchase orders and handle appropriate entries/requests into relevant financial and payment systems
* Support Clinical Pricing & Payments Group in setting up sites
* Track contract progression using appropriate systems
* Amend and terminate contracts as necessary throughout lifecycle of study
* Store and archive contracts and budgets in appropriate systems
* Maintain payment records and provide assistance with audit review records
* Responsible for reviewing and approving, with Law guidance, applicable changes within ICF part 2.
* Responsible for the contracting process and/or point-of-contact for vendor for locally outsourced studies
* Responsible for the Clinical Trials Insurance process
* Participate in appropriate site/legal meetings as required to resolve contract issues
* Participate in appropriate site/finance meetings as required to resolve payment issues
* Maintain party information and contract activation in Contract Generation System
* Approve or reject clinical invoices
* Process and track Confidential Disclosure Agreements as appropriate
* Manage contracting process with Clinical Trial Related Consulting Agreements
* Manage all study-related Site payments not managed by Clinical Pricing & Payments Group
Additional Skills & Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience
* Recent (within last 3 years) contract and budget negotiation experience in a clinical trial setting.
* Directly involved with the negotiation of terms for various contract types (CTA, CDA, Master Agreements, etc) and site budgets. We want to make sure they are not just a "middle man" passing the contract from clinical trial site/sponsor to legal.
* The following competencies:
* Attention to detail
* Negotiation skills
* Organizational Skills
* Relationship management
* Time management & prioritization
* Flexibility
* Written and oral communication skills
* Good working knowledge of common software packages (e.g. Office 365 esp. Excel, Word, SharePoint, Microsoft Teams, SAP)
* Data analysis and presentation skills
* Problem solver
* Team work
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
