CDMA Contract Services Manager

Company: Disability Solutions
Location: Pleasanton
Posted on: October 3, 2024

Job Description:

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionWe advance science so that we all have more time with the people we love.At Roche Diagnostics, we develop diagnostic tests, instruments and digital solutions with the power to transform healthcare for people around the globe.Roche is committed to not only advancing diagnostic solutions that can support healthcare professionals in making critical decisions for their patients' health, but also improving the way these essential tools are integrated into health systems around the world, at a lower cost, while still achieving the best possible outcomes.The CDMA Contract Manager (manager) will have key responsibilities and work cross functionally with internal and external stakeholders, including Legal, Procurement and Finance. The manager will build and maintain strong relationships to meet business goals and ensure operational excellence.

• You will draft, review, and negotiate clinical trial agreements (Master Service Agreements, Work Orders, and Clinical Trial Agreements) and site budgets with US and ex-US institutions.
• You will evaluate changes in study protocols to determine the impact on clinical trial site budgets; you will develop, negotiate, and finalize budget amendments; you will focus the majority of your time related to the conduct of clinical trials.
• You will provide continuing support on executed agreements (e.g., drafting amendments, extensions, and terminations, interpreting contractual language in response to issues or questions that arise); you will adhere to regulations, guidelines, and standard operating procedures, and ensuring contract compliance.
• You will work closely and communicate with members of the Lifecycle Finance teams and other internal stakeholders; provide timely updates on contract and site budget status', identifying and escalating any potential critical path items as appropriate.
• You will track, maintain, and update assigned contract information within the CDMA tracking tools, to ensure completeness and accuracy.
• You will perform other tasks that may be assigned from time to time to support the overall CDMA function.This is a remote based position.There is no relocation support for this position.Who You Are:(Required)
  • You have a Bachelor's degree in Life Sciences, Business Administration, or a related field; (An advanced degree (e.g., Master's or MBA) can be a plus.)
  • You have demonstrated experience in clinical contract management, particularly within the diagnostic industry; you have demonstrated negotiation and communication skills; you have an understanding of legal terminology and concepts related to clinical trials and contract law; you are familiar with compliance requirements and ethical considerations in clinical research.
  • You have a proven track record of negotiating and managing a high volume (30-40 ongoing contracts) of clinical trial agreements, vendor contracts, and other relevant legal documents; you have demonstrated experience reviewing/evaluating contract terms and identifying potential risks or issues related to clinical studies in a high-paced research environment.
  • You have demonstrated knowledge of all clinical trial processes, phases, and regulatory requirements (e.g., ICH-GCP guidelines); you have demonstrated working experience with various clinical trial stakeholders, including CROs, investigational sites, and regulatory bodies; you have strong analytical skills to interpret and ensure compliance with contracts.
  • You have demonstrated problem-solving skills with experience in conflict resolution and the ability to handle complex contract disputes; additionally, you have the ability to anticipate potential challenges and develop strategic solutions.Preferred:
    • You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities.
    • You have strong written and verbal communication skills; including the ability to communicate with all levels within the organization; the ability to facilitate clear and concise interactions with internal and external stakeholders.
    • You have experience working collaboratively, fostering professional and constructive relationships as part of a team; while also working independently to produce data and meet challenging timelines and goalsThis is a remote based position.There is no relocation support for this position.The expected salary range for this position is $67,550 - $148,070. Actual pay will be determined based on experience, qualifications,geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.This position also qualifies for the benefits detailed at the link provided below.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form .

Keywords: Disability Solutions, Sunnyvale , CDMA Contract Services Manager, Executive , Pleasanton, California