Clinical Trial Manager
Department: 300 - Clinical Operations : Vanessa Tassell
Employment Type: Full Time
Reference Number: 1706746
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib (MRTX849) and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule, potent and selective KRAS G12D inhibitor in preclinical development.
Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a Phase 3 trial of sitravatinib in combination with nivolumab in NSCLC.
The Company has initiated plans to prepare for the commercialization of adagrasib by establishing its commercial and medical affairs team. Mirati's ambition is to continue to recruit and a build a world-class, high-performing team with a shared passion and dedication for transforming the future of cancer treatment.
We are Mirati
Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.
Why join us?
Our pipeline is one of the most robust and exciting in the industry and fuels our ambition to make great strides in the fight against cancer. By joining Mirati, you will become part of a leading biotech company with a team of talented professionals dedicated to bringing the latest innovations in cancer treatment to patients. With a focus on teamwork and a commitment to do everything we can to support healthcare professionals in their effort to care for patients, we are well positioned to raise expectations for what companies can do to advance cancer care. We are passionate and dedicated, nimble and fast and are committed to empowerment to enable speed and high-quality customer service. While we go about it, our commitment to do first what is right is unshakable and we promise to put patients first in all that we do.
The Clinical Trial Manager (CTM) 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 in order 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.
- 5 years of direct site management (monitoring) experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through 4 studies, both domestic and international.
- 3-5 years study oversight as an in-house CTM (e.g., CRO/vendor oversight)
- Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
- 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.
Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards 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 informations, 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.