About Us
Roche Molecular, one of four customer-focused areas of Roche Diagnostics Solutions, develops, manufactures and supplies a wide array of innovative molecular diagnostic products, tests, platforms and technologies used to identify and quantify DNA and RNA from different organisms.
Manages multiple exploratory research and clinical projects (sometimes as part of a program) from initiation through contract completion. Primary point of contact to Pharma partners.
* Manages tactical coordination of timelines for all pharma collaboration projects within the Pharma Partnering Business:
* Develops pharma services plans, establish and coordinates timelines for assigned project and functions
* Manages execution of cross-functional plans and track of progress of activities
* Generates, manages and performs internal audits with QA on clinical study binders
* Clinical Study Protocol Management (e.g., protocol adherence, financial aspects, IRB notifications/submissions)
* Write new procedures (and work with QA to update current procedures, as needed, with respect to GCP and protocol adherence)
* Ongoing review, maintenance, and follow-up of Essential Documents for filing into physical and electronic study binders (e.g., missing documents, review documents for Good Documentation Practices)
* Daily monitoring of all study-related quality records to ensure proper management under GDP and GCP.
* Tracks, maintains and communicates project reports and clinical study data to Pharma and Roche clients.
* Organizes activities ensuring completion of the clinical study projects on schedule and within budget constraints; maximizes project resources.
* Implements/pulls in best practices that foster continuous improvement by ensuring knowledge, and experience exchange.
* Identifies gaps, potential bottlenecks or delays and challenges assumptions
Proposes options to close gaps and get projects back on track.
* Working closely with lab personnel and Lab Director to communicate/provide updates to COBM and to Pharma, as applicable
* Organizes and manages project meetings, including setting agenda, leading meeting discussion, ensuring minutes are taken and tracking of project risks and action items. Takes action to direct, analysis, and solutions of problems in a timely manner.
* Review conformances on a daily basis and being able to make decisions on if nonconformances impact a Pharma Client’s study
* Participates in Quality Assurance/Quality Control and/or review of data as necessary.
* Provides regulatory guidance and facilitates collaboration between Pharma and Regulatory.
* Mentor and coach clinical study project managers.
* Other duties as assigned by management.
Qualifications
Education
* BS. in Life Sciences or in a related field required
* MS/PhD in Life Science or related preferred
* Specific Project Management training, or Clinical Research training and/or certification preferred.
Experience
* 8-12 years of project and/or clinical trial coordinator/management experience in a regulated, CRO, diagnostic, and/or pharmaceutical industry with regulated documentation.
* Experience with clinical trial management and bio-sample (clinical testing) management and quality assurance.
* Experience with projects that require rapid activity/milestone achievement.
* Previous experience with standard project management process (PMP) desired.
Are equivalencies acceptable?
No
Knowledge, Skills, and Abilities
* Knowledge of Diagnostic and/or Pharmaceutical industry and relevant diagnostic area.
* Strong knowledge with partnership management and working with partners.
* Strong knowledge and understanding of Clinical Trials management and bio-sample (clinical testing) management and process flow.
*Strong knowledge of IRB/Ethics committee, Regulatory (Pharma/Medical Device) oversight processes.
* Understanding of Quality and Regulatory processes including GCP ICH Guidelines.
* Strong negotiation and meeting facilitation skills.
* Strong written and verbal communication skills
* Good leadership and project management skills. Displays effective interpersonal skills and ability to work in a team environment
* Proficiency with word processing, spreadsheet, database and email software (e.g., Google Mail, Google Calendar, Google Sheets/Microsoft Excel)
* Working knowledge of MS Project and/or Smartsheets
Microsoft Word, Laboratory Management Information Management Systems).
* Ability to multitask and coordinate own day-to-day activities. Ability to work under time pressure while maintaining high standards of precision and data quality.
* Ability to apply specialized knowledge and skills in the functional areas, particularly interfacing with laboratory, scientific, and medical staff.
Travel Requirements
* Based on business needs
The expected salary range for this position based on the primary location of San Jose, CA is $ 116,600.00 – $216,600.00. 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.
Relocation benefits are not available for this job posting.
Who we are
At 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 .
Roche is an Equal Opportunity Employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
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