Apex Systems, Inc Senior Contracts Manager - NJ - 901283 in Madison, New Jersey
I. POSITION SUMMARY:
The role of the Contract Manager is to create, negotiate and execute all study contracts, contract amendments, and budgets required for Clinical Trials (Phases II-IV.
II. PRIMARY JOB RESPONSIBILITIES:
Clinical Trial Agreement (CTA) Management
Develop CTA per patient budgets using Grants Manager
Draft study specific CTA templates.
Finalize CTA templates and per patient budgets with study teams.
Negotiate and establish pre-approval and approval workflows; review roles, task timelines and responsibilities; and negotiation parameters with study teams.
Draft, negotiate, and execute site specific CTAs within established study timelines and study budgets.
Develop, draft, and negotiate CTA amendments within established study budgets.
Assist with managing the Data Driven Payment process for assigned studies.
Lead and coordinate CTA management for large studies.
Lead and coordinate CTA management for all studies within a project.
Ensure contracts are executed within fair market standards as appropriate.
Answer questions and resolve problems concerning all assigned studies and individual contracts.
Track workflow and contract cost for all assigned studies and individual contracts.
III. ADDITIONAL JOB RESPONSIBILITIES:
Engage in process improvement initiatives both inside and outside the Contracts Management Group (CMG).
Provide some mentoring to junior associates within the CMG.
Assist with developing and maintaining CMG procedures for contract management as needed.
Support developing processes, standard templates, and quality definitions and metrics as appropriate.
IV. POSITION QUALIFICATIONS:
3-5 years of experience creating, negotiating and executing Clinical Trial Agreements in a pharmaceutical or biotech company or Contract Research Organization (CRO).
Knowledge, Skills, and Abilities:
Knowledge of the pre-clinical, clinical, and periapproval drug development process required.
Advanced skills in Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft Access
Experience using Adobe Acrobat Professional and Microsoft Office SharePoint.
Proficiency with specialized industry databases such as GrantPlan a plus.
Must possess excellent skill/ability in the following:
Dealing with Difficult People
To apply for this position please send resume to:Vickie Dagit, email@example.com
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at firstname.lastname@example.org or 844-463-6178.
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We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.