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Analyst, Clinical Contracts

3 months ago

Irvine, United States Ledgent Technology Full time

Medical Device client is seeking a Medical Device Clinical Trial Contract Analyst for a 6+ mo contract in Irvine, CA (hybrid)

Max Pay - $61.47

Must haves for this role:

  • Individuals must be from an enterprise background with companies like J&J, Allergan, Boston Scientific, etc. The team is open to high level CRO's as well.
  • Well versed in the full clinical contract lifecycle (drafting, redlining, amendments, closing etc.)
  • Previous experience working directly site physicians, principal investigators, and sponsors.
  • Proven track record of being a part of high-level strategic conversations and contributing to said discussions.
  • Proficient with Excel and SharePoint.

Summary:
 Negotiate and develop contracts associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts.

Key Responsibilities:

  • Initiate, draft, redline, and negotiate complex contracts based on substantial knowledge of financial/fair market value, regulatory and clinical requirements
  • Negotiate trial budgets with clinical sites to ensure compliance with company-approved guidelines and alignment with fair market value utilizing approved budget templates
  • Collaborate with key stakeholders (e.g. Clinical Affairs, Legal, Compliance) to provide guidance on functional contract terms to secure appropriate approvals and mitigate risk exposure to the company
  • Negotiate complex contracts with external partners in accordance with local regulations
  • Analyze need for contract amendments or renewals and make recommendations, and/or negotiate changes, to terms and conditions
  • Submit proposed final draft and supporting documentation utilizing Edwards-qualified systems for contract approval and secure appropriate signatures within specified signing authority
  • Identify opportunities for process improvement in collaboration with cross-functional teams; present and implement process improvement plans to management and/or key stakeholders
  • Other duties assigned by Leadership


Additional Skills:

  • Proven expertise in Microsoft Office Suite, including PowerPoint, Excel, and Word and ability to operate general office machinery
  • Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Demonstrated problem-solving and critical thinking skills
  • Knowledge and understanding of Client policies, procedures and guidelines relevant to contract negotiation and administration
  • Knowledge of medical terminology and healthcare regulations (e.g. HIPAA and Sunshine Act)
  • General knowledge of clinical research and operations acumen
  • Ability to manage confidential information with discretion
  • Ability to manage competing priorities in a fast paced environment
  • Track record demonstrating accomplishment in assigned work in a team environment, including acumen needed for successful interactions with interdepartmental teams, key contact representing the organization or contracts or projects, and with senior internal and external personnel on significant matters often requiring coordination between organizations


Education and Experience:
* Bachelor's Degree or equivalent in related field
* 2-4 years of MEDICAL DEVICE Clinical Trial Contract experience required

Desired Skills and Experience

Medical Devices, Clinical Contracts, Clinical Research, Excel, SharePoint, risk assessment, Payment Tracking, Compliance, Contract Negotiation, HIPAA, Fair Market Value (FMV)

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.