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The Position

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.

The Opportunity:

Your responsibilities in this role will include:

• 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.

Who You Are:

(Required)

• You have a Bachelors degree in Life Sciences Business Administration or a related field; (An advanced degree (e.g. Masters 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 goals

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $87300 - $162100.00. 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.

Benefits

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.