Manager, Clinical Contracts
Summary of Objective:
Works closely with global clinical business development personnel, internal departments, outside counsel, in-house counsel and respective clients to draft, negotiate and execute customer agreements and all legal documents required to support the business relationship, including master services agreements, proposals, confidentiality agreements and work orders. Tracks work in progress to ensure timely completion. Prepares operational summaries of all executed master service agreements, summarizing key contract terms for the operations and quality teams.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
1. Draft, review and negotiate proposals, master services agreements, confidentiality agreements and other customer agreements.
2. Draft, review and negotiate amendments to above agreements as required.
3. Work closely with internal and external counsel to assess challenges that arise in negotiations, and to develop and present options to address same for both internal and/or client review.
4. Work closely with the Senior Vice President of Clinical Services and business development representatives to align on negotiation strategy, address client revisions to agreements and develop appropriate alternatives in order to finalize agreements.
5. Correspond with and conduct meetings with business development team, internal departments, outside counsel and clients to review agreements and negotiate terms.
6. Maintain global templates of the clinical agreements to standardize terms/conditions, scope language and other required clauses and update from time to time as needed, with input from business team, in-house counsel, Clinical Contracts team, and outside counsel as appropriate.
7. Prepare operational summaries of master services agreement for the operations and quality teams to ensure the company’s compliance with agreed terms.
8. Proactively initiate discussions to obtain answers, collect business process information, and work with others in a positive and collaborative manner.
9. Manage and prioritize competing requests for multiple parties to ensure all tasks are completed on time.
10. Possess ability to solve complex problems with minimal guidance based on individual judgment and prior experience.
11. Understand and comply with all appropriate Company, cGMP, and GCP policies, procedures, rules.
12. Perform other duties as assigned by Manager/Supervisor.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
- Stationary Position: 3/4 of the day and up.
- Move, Traverse: Up to 1/4 of the day.
- Operate, activate, use, prepare, inspect, or place: None
- Install, place, adjust, apply, measure, use, or signal: None.
- Ascend/Descend or Work Atop: None.
- Position self (to) or Move (about or to): None.
- Communicate or exchange information: 3/4 of the day and up.
- Detect, distinguish, or determine: None.
On an average day, the individual can expect to move and/or transport choose an item
less than 1/4 of the day.
This position may have the following special vision requirements.
☐ Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception
☐ Ability to focus ☒ No Special Vision Requirements
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
Ø Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.
The noise level in the work environment is typically quiet.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- A minimum of five years practical experience of leading face-to-face or tele/video conference situational contract negotiations
- Bachelor's Degree in a related field and/or 5 years related experience and/or training specific to contract pharma/pharma services agreements, and clinical trial services agreements in particular.
- Paralegal Certification or JD or combination of directly relevant experience and complementing qualifications.
- Leadership/management capabilities
- Ability to present a respectful and professional demeanor at all times when interacting with customers.
- Ability to listen to the Client’s position, concerns and arguments and address same constructively and professionally.
- Ability to articulate Company’s position, arguments and justification.
- Attendance to work is an essential function of this position.
- College Level Mathematical Skills
- Advanced Computer Skills: Ability to utilize MS Office; including proficency in Excel, Word & Powerpoint
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
- Previous experience utilizing Sales force software.
- Ability to effectively present information to various people as the job requires.
- Ability to work independently and/or part of a team.
- Ability to display a willingness to make decisions.
- Ability to identify and resolve problems in a timely manner.
- Ability to set and achieve challenging goals.