Sr. Manager, Clinical Data Management
Employment Type: Full Time
Reference Number: 2445303
Job Description Summary
The Sr. Manager, Clinical Data Management 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 Sr. 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 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 design and development of electronic Case Report Forms (eCRFs) with clinical study team
- Develop edit check 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.
About Mirati Therapeutics
Mirati Therapeutics is a late-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, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
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. Together, we own Mirati's success.
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.