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Description:

• Expertly reviews and approves clinical trial and related agreements in accordance with applicable regulations and academic requirements. Displays leadership by providing timely and effective guidance on negotiation strategies and industry “best practices.”
• Coordinates with Office of General Counsel, Office of Risk Management and Office of Research Commercialization.
• Meets regularly to review agreements and business decision issues.
• Independently manages and performs the review, interpretation, negotiation and processing of clinical trial, nondisclosure, and associated contracts from a legal, business, and technical perspective.
• Develops negotiation strategy, drafts and negotiates contracts mutually agreeable and Sponsors that comply with policies.
• Initiates and participates in meetings and teleconferences as needed.
• Manages stakeholder relations with timely and professional status updates on contract status matters. Identifies, evaluates, and resolves contract matters.
• Responsible for contract administration and review of contract packages for validity, completeness and accuracy. Maintains complete electronic contract files and negotiation history.
• Collaborates with OHRS finance team and other internal stakeholders to verify budget and ensure delivery of fully executed contracts in support of timely study start-up to meet departmental and organizational goals.
• Distributes work order documents to participating health system sites when Scientific Review Board (SRB) approves clinical trial.
• Serves as subject matter expert in clinical and research contract management, ensuring compliance with all policies.
• Updates project dashboards in OnCore® on project contracts and site contracts status
• Serves productively on Department Committees.
• Attends 80-90% of staff/committee meetings unless excused or off duty.
• Maintains knowledge of and participation in Performance Improvement (PI) activities by collecting data within established timeframes, identifying and reporting potential PI problems to Manager, and willing participation in the design and implementation of changes in the department based on PI results.
• Attends Training Programs, Modules, workshop, and seminars sponsored by OHRS; and meetings with the Principal Investigator, when directed by supervisor, to keep up-to-date on project objectives.

Additional Skills & Qualifications:

• Clear experience of negotiating both industry-sponsored and non-industry sponsored clinical trials
• Extensive experience in associated regulations governing clinical research
• Strong understanding of policy and practice governing clinical research within a large institution
• Strong communication skills (verbal and written)
• Ability to communicate complex information in English effectively both verbally and written to all levels of staff,

management and external partners

• Ability to work well with all levels of staff both within an organization, across functions, and across cultures;

demonstrated ability to work effectively in cultures and environments other than one’s own

• Ability to meet or exceed customer service standards and expectations in assigned unit(s) and/or across multiple

areas in a timely and respectful manner

• Self-motivated, detail-oriented and capable of handling significant responsibility, as well as, shifting priorities;

exercises discretion; takes initiative to resolve problems

• Anticipates needs, responds quickly, provides guidance and support, monitors and follows up as required
• Must have a passion for excellent customer service and commitment

Experience Level:

Intermediate Level

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.