Principal Clinical Data Manager
Department: 310 - Biostatistics : Thian Kheoh
Employment Type: Full Time
Reference Number: 1576275
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?
The Principal Clinical Data Manager is responsible for the oversight and management of clinical data management activities conducted on Mirati clinical trials from study start-up to database lock. This role will collaborate with CRO vendors and cross-functional team members for protocol review, eCRF development and standardization, database design specifications, data review and coordination of timely delivery of complete, high quality and integrous clinical trial data deliverables. The Senior Manager, Clinical Data Management at Mirati will ensure quality standards and deliverables as per Good Clinical Data Management Practices (GCDMP) and will adhere to ICH GCP guidelines. This position reports into the Associate Director, Clinical Data Management.
- Oversee all data management activities for assigned studies performed by CRO
- Serve as the Mirati DM point of contact with cross-functional team members, both internal and external to ensure on-time, quality deliverables per overall study timelines
- Oversight of CRO/vendors to ensure quality, efficiency and consistency across assigned studies
- Implement the data quality review strategy of clinical trial data in collaboration with cross-functional team members for assigned studies
- Represent DM function at assigned study team meetings
- Responsible for reviewing and ensuring quality of key DM documents, DMP, data review plans, eCRF Completion Guidelines, Data transfer specifications
- Lead User acceptance testing activities for database and edit check specifications
- Oversee vendor data reconciliation (i.e. IXRS, central laboratory data, SAE) within the clinical database to include quality control review of queries, query responses, manual and programmed custom reports
- Manage Mirati user administration and access to the EDC system for assigned studies
- May serve as subject matter expert in assigned area(s)
- Participate in the development of sponsor Data Management SOPs, work instructions, and process improvements
- Mentor junior staff on areas associated with tasks on assigned study
- Maintain internal data management study level documentation in audit ready status
- Perform other duties as requested by management
What is Required:
- BS or MS, preferably in the scientific/healthcare or related field
- 8+ years industry experience as Lead Clinical Data Management in the Pharmaceutical or Biotechnology industry
- Experience in oncology Phase I, II, and III studies preferred
- Ability to succeed in a fast-paced, mid company sized environment with the ability to manage a variety of projects simultaneously. Must be self-starter and function under minimal supervision
- High attention to detail including a proven ability to manage multiple competing priorities
- Working knowledge of GCP, FDA regulations, ICH guidelines, CDISC, CDASH, 21 CFR Part 11 and GCDMP
- Detail oriented, with strong communication and prioritization skills, critical thinking, planning and organizational skills
- Proficient working knowledge of EDC (Medidata Rave preferred) and IXRS/IRT solutions
- Experience working in an outsourced clinical data management model with full service global CROs and providers
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.