Senior Analyst, Clinical Contracts Transcatheter Mitral And Tricuspid Therapies (Tmtt)

Edwards Lifesciences Corp Irvine , CA 92606

Posted 4 days ago

This is an exciting opportunity for you to join a team boldly designing transcatheter mitral and tricuspid therapies from the ground up. Edwards' Transcatheter Mitral and Tricuspid Therapies team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients' lives around the world.

The Senior Analyst, Clinical Contracts will negotiate and develop contracts associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts.

Essential Job Functions:

  • Initiate, draft, redline, and negotiate 3rd party complex contracts based on full knowledge of financial, regulatory and clinical requirements

  • Collaborate with key stakeholders to provide guidance on contracts terms and conditions. Identify risks and key stakeholders to the company

  • May track business unit and payment milestones against contract terms. Resolve payment queries and confirm contract compliance

  • Develop, assess and improve processes for tracking and reporting business unit payment and compensation information to meet all applicable regulations and processes

  • Analyze need for contract amendments or renewals and make recommendations, and/or negotiate changes, to terms and conditions

  • Other incidental duties assigned by Leadership

#LI-MO1

#AS

Required Education/Skills/Experience:

  • Bachelor's degree in related field required; Advanced degree in related field preferred

  • 5 years of previous related experience in contract negotiation/administration and financial tracking/analysis against contracts

  • Experience in healthcare related contracts

  • Experience with Clinical Trial Agreements

Preferred:

  • Contract or paralegal certification preferred

  • Experience in international contract administration preferred

Additional Talents and General Expectations:

  • 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

  • Full knowledge and understanding of Edwards policies, procedures and guidelines relevant to contract negotiation and administration

  • Full knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)

  • Full understanding of regulatory requirements (e.g., CFR, GCP) and documents

  • Advanced proficiency in Microsoft Office Suite, including Excel, and Word

  • Excellent written and verbal communications skills

  • Advanced problem-solving skills

  • General knowledge of clinical research and operations acumen

  • Ability to manage confidential information with discretion

  • Strict attention to detail

  • Ability to interact professionally with all organizational levels

  • Ability to manage competing priorities in a fast paced environment

  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects

  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manager Clinical Contracts Transcatheter Mitral And Tricuspid Therapies (Tmtt)

Edwards Lifesciences Corp

Posted 4 days ago

VIEW JOBS 3/22/2019 12:00:00 AM 2019-06-20T00:00 This is an exciting opportunity for you to join a fast-paced, dynamic team boldly designing transcatheter mitral and tricuspid therapies from the ground up. Edwards' Transcatheter Mitral and Tricuspid Therapies team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients' lives around the world. The Manager, Clinical Contracts will manage a clinical contracts team with responsibility for the full clinical contract lifecycle including partnering closely with clinical study teams, hospitals, vendors, consultants, Legal, Finance and Compliance groups to develop and lead the execution of a variety of clinical contracts while applying legal and clinical expertise. Depending on experience level, we are open to hiring at the Associate Manager or Manager level. This role is located in Irvine, California Essential Job Functions: * Manage and oversee the work of assigned team within own function and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department * Draft, negotiate, and lead the execution of the full clinical contract lifecycle for a variety of complex contract types (e.g., clinical trial agreements, non-disclosure agreements, and vendor contracts), utilizing appropriate Edwards systems (e.g. ECLM). * Assess needs for contract and budget amendments and provide guidance to key stakeholders, make recommendations, and/or negotiate changes, to terms and conditions while mitigating risks to the company * Develop study budgets based upon fair market value assessments with in-depth understanding of clinical project scope in collaboration with clinical study teams. * Develop processes to maintain and track business unit and payment milestones against contract terms utilizing CTMS by working with study team, database developers and data management. * Provide clinical team oversight and work direction with regard to clinical systems such as the Clinical Trial Management System (CTMS), electronic Trial Master File, and other operational systems. * Approve payment issuance in accordance with contract terms. * Develop and lead the implementation of continuous process improvement projects * Other duties as assigned by Management #LI-MO1 #MI Required Education/Skills/Experience: * Bachelor's degree in related field required * 10 years of related experience (8 years for Associate Manager level) with Clinical Study Agreements, Informed Consents, Consulting and Vendor contracts along with knowledge of supplier qualifications processes * Experience inclusive of at least 5 years dedicated to clinical contract negotiation/administration specific to Clinical Trial Agreements required * 4 years of people management experience (2 years for Associate Manager level) with the ability to lead and inspire a clinical contracts team * Depending on experience level, we are open to hiring at the Associate Manager or Manager level. Preferred: * Contract or paralegal certification preferred * Experience obtained in Medical Device, CRO, Biotech, Pharmaceutical industries strongly preferred. * Experience in international clinical study contract administration preferred. Additional Talents and General Expectations: * Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations * Experience in healthcare related contracts preferred * Proven expertise in Microsoft Office Suite and related contract systems * Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives * Excellent problem-solving and critical thinking skills * Recognized as an expert in own area with specialized depth within the organization * Expert knowledge and understanding of Edwards policies, procedures and guidelines relevant to contract negotiation and administration * Expert knowledge of medical terminology and healthcare regulations (e.g. HIPAA and Sunshine Act) * Expert knowledge of all legal aspects of contracting and the ability to understand contract language and quickly identify/communicate any risks or liabilities * Strict attention to detail * Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization * Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment * Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical contracts to the business * Ability to manage competing priorities in a fast-paced environment * Ability to provide guidance to others on area of expertise Edwards Lifesciences Corp Irvine CA

Senior Analyst, Clinical Contracts Transcatheter Mitral And Tricuspid Therapies (Tmtt)

Edwards Lifesciences Corp