Clinical Contracts Manager, Research & Development Legal - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Summary:

We are looking for a Contract Manager based on the East Coast to support our clinical trial programs. The Contract Manager will be responsible for providing contract management to support the client's clinical trials.  The Contract Manager consults and collaborates with legal counsel, business contract owners, key stakeholders (i.e. compliance, privacy, procurement, operations), CROs and clinical trial sites within and outside the United States.  This individual will also be responsible for timely preparation, drafting, negotiation and administration of contracts.  

The successful candidate will have strong contract negotiation, contract management, and communication skills.  The successful candidate will be distinguished by their ability to negotiate a high volume of research agreements with an attention to detail.  The successful candidate will be distinguished in their ability to collaborate with Clinical Development and the Legal team to prioritize agreements, as well as, execute contract and other legal strategies.  It is expected that the Senior Contract Manager will be a highly effective collaborator and communicator. A successful candidate will have a positive attitude and be effective in a fast-paced environment.

Key Responsibilities:

Contract Negotiations and Reviews

• Review and negotiate confidentiality agreements (CDAs), Clinical Trial Agreements (CTAs) and Informed Consents (ICFs) either directly or as escalated by CROs. 
• Identify and escalate contract terms to appropriate contract owners, attorneys, and other appropriate stakeholders, in a timely manner.
• Build strong working relationships with CRO contracting staff, as well as, contracting staff at medical institutions to facilitate quick contract executions and conflict resolutions to ensure efficient conduct of clinical trials.           
• Track and drive contracts to resolution, including identifying remaining contracting issues, identifying appropriate stakeholders to reach decisions, and convening meetings to drive efficient decision-making.
• Identify and effectively communicate priorities and urgencies to applicable stakeholders.
• Participate in cross-functional teams to ensure contract executions and strategies are achieving targeted goals 

Contract Administration / Operational Management

• Serve as an expert in Alnylam's contract management system and processes.
• Work closely with Legal Operations and contract management system team to ensure contracts are properly managed in system and develop enhancements, improvements and updates.
• Partner with Legal and other colleagues to address and solve day-to-day contracting issues and proactively troubleshoot and implement short-term and long-term contract improvements and efficiencies.
• Support and manage contract templates and guidelines, as requested. Track negotiated terms across agreements and identify potential updates to contracting guidelines.
• Propose updated contracting guidelines, as needed.

Qualifications:

• Undergraduate degree required, paralegal certificate preferred.
• Minimum 5 years of contracting experience.
• Direct experience negotiating CDAs, CTAs and ICFs either in a pharmaceutical/biotech company or CROs.  
• Experience negotiating within contract management system (CMS) required.
• General understanding of applicable laws and regulations, as well as, legal risks, impacting research and development at a commercial-stage, biotech company (including confidentiality, intellectual property, anti-kickback/anti-bribery laws, GCP/ICH, FDA regulations, privacy laws)
• Strong written, oral communication, interpersonal, and organization skills.
• Ability to work independently, as well as, in a team environment.
• Ability to effectively prioritize workload and communicate priorities.
• Ability to work and adapt in a complex, dynamic organization handling multi-faceted projects with tight timelines.
• Interacts effectively and productively with all levels within an organization in a calm, professional manner.
• Motivated to work in a fast-paced environment.
• Detail-oriented.

EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.