Clinical Site Manager for Near Patient Care

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.

At Roche Diagnostics Solutions (RDS) our mission is clear: to diagnose earlier develop faster and personalize treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally.

We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians and leveraging digitalization and new technologies we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster.

Our work spans the entire product lifecycle from discovery to post-launch. By collaborating with internal teams external partners and patients the CDMA chapter provides crucial medical insights designs and executes clinical studies and offers on-market support. Ultimately we generate comprehensive clinical evidence that demonstrates product safety effectiveness and scientific validity - facilitating smooth product registration adoption and reimbursement globally so we can save lives and improve patient quality of life.

The Opportunity

• Act as the primary contact and clinical trial expert for assigned study site personnel coordinating training and technical assistance to ensure successful study execution.

• Perform site assessments and qualification visits to support site selection and activation including contracting and regulatory compliance (IRB/EC/Health Authority).

• Develop and manage key study site documentation (e.g. Study Monitoring Plans informed consent forms source documents) while offering technical expertise for protocol reviews.

• Oversee CROs for site management activities escalate operational issues and collaborate with international investigators to ensure high-quality execution.

• Execute site management activities for sponsored studies across all study phases (start-up conduct close-out) for registrational and non-registrational purposes.

• Validate product performance claims supply data for critical regulatory submissions and gather actionable feedback from clinical laboratories and sites.

• Collaborate closely within cross-functional local and global virtual study teams fostering an inclusive high-performing environment.

Who You Are

• You hold a Bachelors degree in a Health Science Clinical Diagnostics Engineering field or equivalent

• You have 3 years of experience in the Medical Device or Diagnostics industry with direct experience in IVD Medical Device or Drug clinical studies.

• You have 1 years of experience in cardiovascular/metabolic indications or Point of Care / Near Patient Care settings

• You demonstrate a solid understanding of ICH-GCP guidelines in clinical trial execution.

• You show strong decision-making and problem-solving skills taking accountability while adapting fluidly in a fast-paced collaborative team environment.

Preferred Experience:

• You have experience in emergency department settings

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of Indianapolis IN is $. 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

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.