Senior Medical Data Specialist
Woodcliff Lake, NJ
At Advanced Clinical, we’re excited to share with you a great opportunity at growing organization for the position of Senior Medical Data Specialist. This role is located in Woodcliff Lake, New Jersey, and will be responsible for selection of appropriate codes using MedDRA and WHO-Drug Dictionaries as well as review of coded items across the study and across therapeutic areas. Ensures accuracy and consistency of coded data within and across protocols and ensures that medical coding deliverables follow regulatory authorities requirements at the global platform.
- Perform medical coding activities from CRF review of codable pages to system coding approval and final sign off of a Clinical Study
- Manages the synonym-lists to ensure accuracy and consistency of the coded data, and adherence to regulatory authorities’ requirements
- Applies GCP principles to ensure all medical coding activities follow SOPs, SWPs and associated guidelines
- Participates in SAE coding reconciliation
- Collaborates with colleagues from study teams across therapeutic areas on coding-related matter Consults with Study Directors to resolve medical coding issues and queries
- Interface with Data Operations during study build coding set up, dictionary migration and resolution on systems issues
- Mentors or supervises Medical Coders and provides training relevant to Medical Coding function
- Responsibility includes generating groupings of similar terms for Adverse Events of Interest or medication of interest
- A minimum of 6 years pharma industry experience
- In-depth knowledge of MedDRA and WHO-Drug Dictionaries
- Knowledge of Clintrial, Inform, ds-Navigator, Central Coding, any other data management databases/eDC systems and coding applications
- Ability to work in a team environment with minimal supervision
- Excellent oral and written communication skills
- Clinical Data Management experience is a plus
- Experience in managing CRO, global team
- Experience in supporting Oncology studies
- Minimum of a Bachelor's degree in Nursing, Pharmacy or other Biological Science
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.