Manager, Clinical Operations
Department: Integrative Sciences
Employment Type: Full Time
Reference Number: 2179760
Job Description Summary
The Manager, Clinical Operations provides trial operational oversight of CROs and vendors (including both U.S. and Ex-U.S. regions). This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans.
- Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines, and organizational objectives of individual protocols/programs.
- Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
- Obtains and maintains in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
- Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
- Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
- Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
- Supports financial management of the study which includes review and approval of site and vendor invoices.
- Supports risk management initiatives
- Supports audit/inspection activities as needed.
- Maintain clinical trial registry entry/updates, as required.
- Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements
What is Required
- BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered.
- 3-5 years site management (monitoring) experience in a Biopharmaceutical or Pharmaceutical company, preferred
- 2-4 years study oversight as an CTM/ CTA (e.g., CRO/vendor oversight), preferred
- Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Excellent understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP & country clinical research law & guidelines.
- Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Demonstrated ability to mentor/lead.
- Hands on knowledge of Good Documentation Practices.
- Performs independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites and therapeutic areas.
- Strong IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and analyze data/metrics and act appropriately.
- Possesses effective time management, organizational and interpersonal skills, conflict management, problem-solving skills.
- High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships.
- Works with high quality and compliance mindset
About Mirati Therapeutics, Inc.
Mirati Therapeutics, Inc. is a clinical-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, MRTX1719, an investigational PRMT5 inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
Mirati has been named a Top Workplace by the San Diego Union-Tribune. Our passionate team are deeply motivated to participate in work that is both important and unique.
Our belief is that transforming the lives of those with cancer is more than a job -- it's the chance to be part of something game-changing.
Urgency, open-mindedness, accountability and collaboration ground our work and behavior. These shared values are central to who we are, what we do and how we do it.
Our culture is one where we challenge norms, have high-risk tolerance, and celebrate an entrepreneurial and courageous attitude full of grit and determination to make a difference. We strive to create a sense of belonging and inclusion - one in which we laugh and have fun as we drive change together.
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision - to unlock the science behind the promise of a life beyond cancer.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) - we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.