Senior Medical Coder
Job Summary
Precision for Medicine is seeking a talentedSeniorMedicalCoderto provide comprehensiveCodingandrelateddata management support throughout all phases of the clinical trial data management directsupervisionworkwitha team of medical codersand sometimes supervising medical coders as a senior you will ensure adherence to Standard Operating Procedures (SOPs) regulatory guidelines and study-specific plans. This role encompasses a range of responsibilities including datacodingandquality reviewwithin a dynamic teamenvironment.
Position Summary:
TheSeniorCoderprovidesCoding in both MedDRA and WHODRUG dictionaries for assigned Studieson afull Operating Procedures / Work Instructions (SOPs/WIs); regulatorydirectives: study specific plans and guidelines will be positionwillperformCoding quality closely with the Coding Manager to ensure priority coding tasks are performed and completedin a timely manner. Working with the Coding manager tofocusthe medical coders as a senior coder.
Essential functions of the job include but are not limited to:
- Perform medical coding of medical termsrelativeto each otherin order toensure medical logic and consistency (MedDRA and WHODRUG)
- Supportother membersas a back-up and/orcodingteam member ensuring continuityresponsiveness andthat tasks are performedin a timelymanner
- Backup the Coding manager for oversight of the team.
- Perform quality control ofCoding
- Provide input intoCodingtimelinesfor overall deliverables.
- Ensure that clinical datacodingdeadlines are met with quality.
- May assess resource needs for assigned projects as needed.
- Review/feedback from allstakeholders
- Conductcoding dictionary upgradeUAT andmaintainquality controlled documentationasneeded
- Responsible for creating revisingappropriate versioningandmaintainingdata managementcodingdocumentation.
- Train clinical research personnel on thestudyspecificCodingrelated itemsas needed.
- Review and querycodingdata according to the Data Management Planand Codingstandards
- Runcodingstatus and metric reporting.
- Assistinparticipatingin the development and maintenance of Standard OperatingProcedures (SOPs) and corresponding process documentation related tocodingactivities
- Trains andensuresthat all data management project teammemberscodinghave been sufficiently trained.
- Communicate with study sponsors and project teams as neededregardingcoding.
- Presentany codingdemonstrations/trainings department/company training sessions projectmeetings
- Perform other duties as assigned.
Qualifications
Minimum Required:
- 5 years experience within Data Management
- Bachelorswithin scientific/science background and combination of related experience
Other Required:
- 5 years performing Dictionary medical coding (MedDRA andWHODrug)
- Proficiencyin Microsoft Office: Word Excel PowerPoint Outlook.
- Able to handle a variety of data managementtaskand oversight.
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral.
- Basic knowledge of drug device and/or biologic development and effective data management
- practices
Preferred:
- Experience ina clinicalscientificor healthcare discipline.
- Oncology and/or Orphan Drug therapeutic experience
Skills:
- Demonstrates strong knowledge of ICH-GCP relevant Precision Oncology SOPs and regulatoryguidance as well as the ability to implement and driveoutcomes
Competencies:
- Motivates project team members to meet timelines and projectgoals
- Focuses on continuous improvement including the ability to make proactive assessments on howto make processes more efficient and people moreeffective
- Resolves project related problems and prioritizes workload to meet deadlines with minimalsupport
- Exhibits a high degree of self-motivation and can work and plan independently as well as in ateamenvironment
- Demonstrates an acceptable degree of professionalism asevidencedby punctuality ability todeliver on commitments an understanding of the service culture and positive interactions withcustomers and teammates including good interpersonalskills
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Required Experience:
Senior IC
About Company
Precision for Medicine is a clinical research organization (CRO) that brings advanced technologies to help maximize insights into patient biology. Contact us today.