Predicine is a molecular insight company developing genomic profiling tests and robust algorithms for cancer diagnostics and monitoring. Our biology-oriented approach to analyzing genomics is advancing the understanding of tumor mutational landscape. We are applying our expertise in genomic profiling to identify elusive cancer-related genetic changes and new biomarker targets across many cancer types. Our advanced cancer genome analysis helps researchers and biopharmaceutical partners accelerate new precision medicine development. At Predicine, we are passionate about our people, technology, and creating a lasting impact in cancer research. If you enjoy challenges, collaborating with others to solve complex problems, and the chance to see your work impact the millions of lives touched by cancer, this is the place to be!
The Clinical Trial Manger reports to the Sr. Clinical Trial Manager or Head of Clinical Development and is responsible for the execution and operation of the company’s global clinical trials. The Clinical Trial Manger carries out all duties related to clinical study design, execution, and operation. This position requires extensive oncology biomarker trial and CRO management experience.What you will get to do:
- Manage the operation and execution of the clinical study process
- Responsible for timely communication with clinical sites and sponsors
- Manage and collaborate with CRO companies for study operation
- Support Dx study protocol’s, preparation and submission to the IRB
- Manage study budget, expense, and other financial aspects related to clinical studies
- Support sponsor audits and/or regulatory agencies for clinical studies
- Oversee data collection, transfer, and storage processes, ensuring compliance with company policies and data integrity standards.
- Collaborate closely with the internal quality and regulatory teams to address issues relating to the execution and operational aspect of clinical studies.
- Monitor study progress and key performance metrics, proactively identify challenges and corrective action to ensure timelines and objectives are achieved.
- Facilitate the preparation, maintenance, and review of study-related documentation, including effective management of the electronic Trial Master File (eTMF).
- Coordinate logistics for sample shipment, liaising with couriers and local customs to ensure timely and compliant delivery.
- Provide comprehensive training to pharma sponsors and clinical site staff to ensure adherence to study protocols and regulatory requirements.
- Conduct site initiation visits (SIVs) to ensure site readiness and understanding of study protocols.
- Manage internal work orders (WOs) and oversee the delivery of testing results to both sites and sponsors, ensuring timely communication and documentation.
Required Education and Skills:
- Bachelor’s degree in biology or healthcare field(s)
- Minimum 5 years + of experience in oncology clinical trial management and/or operation.
- Electronic Trial Master File (eTMF) management experience is required
- IRB and other regulatory agencies communication experience is required
- Oncology biomarker trial experience is required
- CRO management experience is required
- Global prospective clinical trial experience is preferred
- Experience with ISO 13485 and FDA medical device or IVD regulations is desirable.
- Experience and understanding of GCP, GCLP, and other clinical study related regulations and guidelines are preferred.
- Excellent communication and interpersonal skills.
- Proven strong problem-solving ability and root cause analysis skills.
- Meticulous approach with close attention to detail.
- Ability to build internal cross functional relationships and be a self-starter.
- Written and verbal skills must be excellent.
Our Opportunity: Candidate Location: Onsite Hayward, CAEstimate Of Salary Range: $101,000 – $127,000 BaseAll full-time roles in the US come with a robust benefits package which includes healthcare, dental, and vision insurance. Additional benefits include PTO, paid holidays and 401(k) retirement plan. The posted salary range is the estimated base salary range for this position. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly.
Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status.
We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. All your information will be kept confidential according to EEO guidelines. We require all Predicine employee's to be fully vaccinated and provide proof of vaccination on their first day of work. All job offers are contingent upon successful completion of background verification. Applicants must be legally authorized to work in the USA. We are not accepting third party resumes from recruiters, recruiting agencies or 3rd party vendors.
