Senior Manager, Medical Coding - REMOTE
Employment Type: Full Time
Reference Number: 1731872
Job Description Summary
The Senior Manager, Medical Coding (Data Management) is responsible for performing medical coding, creating internal coding guidelines and processes, and managing medical dictionaries. This individual will work with the Medical Directors, Clinical Development Scientists, and Pharmacovigilance to ensure accurate and consistent coding for clinical data deliverables. These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications.
- Performs accurate and consistent medical coding of clinical trial data per MedDRA and WHODrug, and issues queries in EDC as needed
- Manages coding deliverables across clinical studies/programs and ensures coding reviews are completed with respect to overall study timelines
- Develops and implements internal coding conventions, SOPs, guidelines, and processes; ensures adherence to industry standards
- Defines and develops coding review listings in collaboration with Clinical Programming Leads
- Works with the System Administrator to set up and maintain the coding tool/application, and participates in user acceptance testing
- Manages the up-versioning of coded terms, as applicable
- For outsourced studies, performs quality oversight of external vendors who are performing coding, and reviews their documentation and processes
- Participates in the development and implementation of process improvements to support the collection, integration, monitoring, review, and reporting of data
- Manages coding dictionary versions and subscriptions
- Proactively identifies potential study issues/risks and recommends/implements solutions
What is Required
- Bachelor's degree (at a minimum) in a life science or health related field preferred
- 8+ years of Medical Coding experience in the CRO, pharmaceutical or biotechnology industry
- Expertise with MedDRA and WHODrug
- Experience coding in Medidata Rave Coder preferred
- Experience with EDC systems is required
- Experience coding in oncology Phase I, II, and III studies preferred
- Knowledge of industry standards, ICH guidelines, and regulatory requirements
- Proven ability to work both independently and in a team setting
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 KRAS G12C 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 KRAS G12D 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.