Senior Associate, Clinical Data Management
Employment Type: Full Time
Reference Number: 2167340
Job Description Summary
The Senior Associate, CDM is responsible for various aspects of data management activities in support of assigned clinical studies. This individual will collaborate with Clinical Operations, Biostatistics, Medical, Pharmacovigilance and vendors for EDC development, CRF design and standardization, data review/cleaning, database lock, and receipt of final database deliverables to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications.
- Performs data review and reconciliation; ensures accuracy and completeness of the clinical data
- Assists with design and development of electronic Case Report Forms (eCRFs)
- Create Edit Check specifications
- Perform User Acceptance Testing (UAT) on the clinical database
- Develop study metrics reports and other reports as needed
- Work with vendors to set-up and review data transfer specifications as needed
- Perform and QC filing of data management documentation in electronic Trial Master File (eTMF)
- Proactively identifies potential study issues/risks and recommends/implements solutions.
What is Required
- Bachelor's degree in Life Sciences or equivalent experience
- 3+ years of CDM experience in the pharmaceutical, biotechnology or CRO setting
- Prior oncology experience desired
- Knowledge of clinical data management principles, clinical trials process and regulatory requirement
- Able to communicate and collaborate effectively with cross-functional teams
- Working knowledge of ICH, FDA, and GCP regulations and guidelines
- Knowledge of industry standards (CDISC, SDTM, CDASH)
- Experience with Electronic Data Capture (EDC) systems (Medidata Rave preferred) and medical coding dictionaries, such as MedDRA and WHO Drug
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.