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Post: Site Contracts Analyst
Job Description
This position Oversees administration and negotiation processes for site contracts that support projects within Clinical Operations.
Ensures site contract documentation is in compliance with sponsor and Company requirements.
Identifies project and/or individual site contract related problems and works with internal and external team members to provide and implement solutions.
Establishes strong working relationships with customers and internal project teams.
Core Responsibilities
Responsibilities:
1. Works closely with Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog.
2. Actively participates in higher level discussions about overall company goals, departmental objectives, and specific project aims.
3. Tracks and measures project and team progress through collection of cycle time metrics and other quality key performance indicators (KPIs). Communicates metrics, KPIs, and other relevant project information to team and departmental leadership. Proposes solutions to issues that may arise during a project or contract life cycle.
4. Works closely with Legal to harmonize site contract to reflect sponsor's master service agreement terms.
5. Identifies possible contract or process operational risk and proactively works within the team to provide solutions. Establishes strong working relationships with customer and internal project teams. Escalates deviations to department leadership and/or Legal Department.
6. Serves as a resource to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
7. Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
8. Assists in generating amended documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
9. Creates and maintains document status reports and updates department team members on a regular basis; ensures appropriate documentation is maintained for all exceptions.
10. Facilitates contract management functions with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
11. Facilitates the execution of contracts by company signatories.
12. Maintains contract templates and site specific files and databases.
13. Negotiates and prepares contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
14. Serves as communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
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Skills & Attributes
BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
Moderate contracts management experience.
Experience in a contract research organization or pharmaceutical industry preferred.
Strong knowledge of the clinical development process and legal and contracting parameters.
Effective presentation, negotiation, documentation, and leadership skills, as well as strong team orientation and interpersonal skills.
Excellent written/oral communication and organizational skills.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Additional Information:
Location: India
"Industry Type: Pharma/ Biotech/Clinical Research
Job ID: 13904
End Date: 20th May, 2014
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