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Clinical Contracts Associate - II
Ideal candidate will
have a demonstrated track record of success in working collaboratively within a
matrixed environment with other cross functional groups. Position will be
accountable for the drafting, negotiation, and review of global Phase I through
IV clinical site and related ancillary contracts and management of 3rd party
functional service providers (FSPs) involved in the contract management
process. Will manage contract activities for multiple clinical development
programs within a therapeutic area, ensuring adequate FSP staff coverage to
ensure contracts are completed in an accurate, consistent, and timely manner.
Must coordinate with the FSPs, Client Clinical Operations and Client Legal
departments to manage and complete the site contract process throughout study
duration. Responds and resolves complex issues associated with domestic and
international contracts with support from more senior staff and Client Legal
department. Ideal candidate will have demonstrated success in working
collaboratively with stakeholders and other cross-functional groups.
Essential Duties and Job Functions:
Manages the day-to-day activities of multiple areas in complex clinical contracts and finance processes.
Participates in establishing departmental and cross-functional policies and procedures.
Manages site contracting activities for multiple clinical development programs consistently and in a timely manner.
Provides information to Senior Management on contract and finance issues.
Assists CCF staff working on contracts in resolving complex issues relating to contract negotiation or management.
With the support of internal customers and the Legal department, manages the site contract negotiation process for assigned studies.
Demonstrates excellent verbal, written, and interpersonal communication skills.
Demonstrates an in-depth knowledge of clinical research functions.
Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development. (Contracts)
Demonstrates ability to interact on an advanced level with the clinical teams, corporate finance, and project management to provide oversight of clinical budgets and related contractual terms.
Demonstrates a basic understanding of the regulatory implications of contracts as related to clinical research. (Finance)
Completes tasks and projects under minimal supervision as well as demonstrates ability to make critical decisions related to projects and tasks of junior CCF staff.
Demonstrates all the skills of a Clinical Contracts Associate I
Knowledge, Experience and Skills:
4+ years of experience with a BA/BS in a relevant discipline.
Relevant experience typically includes contract negotiation and/or clinical finance
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GDH Consulting, Inc. provides equal employment opportunities (EEO) to all employees and
applicants for employment without regard to race, color, religion, sex, national origin,
age, disability, genetic information, veteran’s status or any other category protected by
law. In addition to federal law requirements, GDH Consulting, Inc. complies with applicable
state and local laws governing nondiscrimination in employment in every location in which
the company has facilities and/or employees. This policy applies to all terms and conditions
of employment, including recruiting, hiring, placement, promotion, termination, layoff,
recall, transfer, leaves of absence, compensation, benefits and training.