Clinical Project Manager

  • location: Northbrook, IL
  • type: Contract
  • salary: $78 - $84.45 per hour
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job description

Clinical Project Manager

job summary:
PURPOSE & SCOPE:

The Sr. Legal Reviewer is the Contracts & Outsourcing (C&O) departments primary liaison with the corporate Legal groups within the company. *This role is responsible for supporting the Global Contracts & Outsourcing Leads (GCOLs) within the department in the oversight and escalation of contracts and legal documents.*(Majority of Job)

The Sr. Legal Reviewer will provide integrated contract language and strategic advice on complex agreements, work orders, and a range of other contract and legal document types. This will include making independent decisions on the contract and commercial risks involved while ensuring that these agreements are in compliance with Astellas legal and compliance policies. Among other things that may be assigned from time to time, the Sr. Legal Reviewer will be responsible for the following:

- Interfacing with Legal, Risk Management, and Compliance as required to resolve issues

- Contributing to the improvement of the contract process by participating in various committees

- Providing training of GCOLs to standardize and improve contracting skills

- Maintaining a system for documenting legal precedents in order to harmonize the decisions made by regional legal and compliance groups

- Leading and/or participating in cross-functional work streams relating to Astellas projects

- Creating contract templates and playbooks for multiple contract types

- Updating playbooks and templates to comply with changing compliance, legal, and/or regulatory requirements

- Creating process tools to drive efficiency (e.g. contract routing tools)

- Strategic operational involvement in process mapping and improvement

QUANTITATIVE DIMENSIONS:

The Sr. Legal Reviewer provides significant contribution to the development and optimization of the C&O strategy and vision, particularly for contract management and issues. This position will also develop a common set of contract templates and processes to ensure consistency and efficiency in the development, delivery, and execution of contracts and outsourcing management. Ensures that appropriate measures are in place to minimize negative impact due to delayed processes, ineffective agreements and inappropriate payment terms.

 
location: Northbrook, Illinois
job type: Contract
salary: $78.00 - 84.45 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
ESSENTIAL JOB RESPONSIBILITIES

1. Contract Review - Provide independent review of legal terms and conditions of various agreements related to Astellas drug development goals. Partners with C&O staff and the groups that it supports to advise on a range of contract options and their legal risks vs. business rewards. First line support for APEB and APGD functional groups on legal matters as they relate to contracts or compliance. Maintains an awareness of current and projected programs and timelines and is able to effectively help meet those timelines. Has a thorough understanding of Astellas templates and negotiation terms and policies with the ability to draft contract language as needed. Monitors legal, regulatory, and compliance conditions that affect contracts. Contributes to the development of new templates. Monitors trends in contract negotiation and legislation to create and adopt the alternative contractual terms in coordination with C&O staff and Astellas Legal.

2. Contract Negotiation - May independently draft, review, and negotiate a variety of research related agreements including master services agreements, services agreements, consultancy agreements, and expert advisory board agreements, and may advise on related legal issues. Analyze requests submitted through C&O representatives and others for modifications to Astellas template contract language, and either provide alternative language options or facilitate getting an opinion from Astellas Legal. Help negotiate contract language with sites/vendors/consultants in support of stakeholders and partners.

3. Study Start-Up - Help study teams understand how contract issues related to specific countries can affect study timelines. Advise on a range of contract term options and their risks/rewards based on the teams objectives in order to realistically guide study timelines. Should be aware of new legislation and regulations and other important matters that could impact Astellas studies in different regions.

4. Process Development and Maintenance - Support continual improvement of contract review processes and departmental contract workflows by evaluating process issues and implementing modifications to solve them. Represents C&O on various committees to support contract and clinical study process improvements and refinements.

5. Legal Training and Support - Proactively communicate and provide training on contract-, legal-, or compliance-related updates, modifications, or issues to management, team members, and various stakeholders, including CROs. Maintain a formal process for ensuring a high level of legal knowledge and awareness within the GCOL team.

 
qualifications:
REQUIRED SKILLS:

  • BS or a BA degree with relevant work experience
  • Legal certification (Juris Doctorate, Qualified Solicitor, LLM etc.
  • Generally 5 + years experience with contract negotiation, analysis, and interpretation required
  • Legal, pharmaceutical, or healthcare experience
  • Excellent interpersonal, oral, and written communication skills required
  • Strong attention to detail
  • Ability to work in environment that tolerates minimal errors
  • Ability to produce quality work under pressure and be able to deliver tasks against tight deadlines
  • Must be able to balance competing project priorities from multiple client groups
  • Judgement and Problem Solving
  • Ability to analyse complex legal issues
  • Ability to quickly acquire knowledge of unfamiliar fields of law
  • Computer literacy, including Microsoft Office Suite, Excel, SAP, and Cognos
  • Must be self-motivated and conscious of both the quality and timeliness of the work completed
  • Complete fluency reading and writing in the English language
PREFERRED:

  • Advanced Degree in Law
  • Experience with budget/financial analysis preferred
 
skills: MS-EXCEL, Contract Negotiation, Contract Law
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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