Department: Global Clinical Operations
Reports To: Director, Medical Coding
Bachelor’s degree or equivalent in a health-related or science field preferred
7+ years of experience in Medical Coding
10+ years of Data Management experience in the pharmaceutical/biotechnology industry covering Phase I – Phase III studies
Provide support for all aspects of dictionary management and medical coding at BeiGene including liaising with internal stakeholders for discussion and resolution of coding related items. Additionally, assist with the management of third-party vendors such as CROs to ensure the delivery of quality coding.
Essential Functions of the job:
- Perform and manage (as appropriate) accurate, consistent and timely coding of clinical trial data using MedDRA and WHODrug including issuing and resolving queries as appropriate
- Perform consistent and comprehensive review of all coding, including outsourced studies
- Adhere to industry standard coding practices as well as company-wide and project specific guidelines
- Assist with the creation and/or review of Standard Operating Procedures (SOPs) and Work Instructions (WIs) involving medical coding
- Evaluate and provide input into coding tools/applications as necessary
- Assist with the upversioning of clinical trial data
- Collaborate with Data Management to ensure timely completion of deliverables pertaining to coding
- Assist with all aspects of User Acceptance Testing involving studies being coded in-house to ensure coding tool is working as expected prior to go-live
- Communicate and implement process improvements pertaining to medical coding activities (as approved/appropriate)
- Assist with the development, maintenance, and documentation of items pertaining to medical coding including but not limited to Global Coding Guidelines, Change Request Logs, Internal or Vendor related coding reports or upversioning documentation
- Provide presentations pertaining to medical coding to internal departments or to external third party vendors as appropriate
- Collaborate cross-functionally to communicate and resolve any issue pertaining to medical coding
- Train, mentor and manage junior staff to ensure competence in coding skills and knowledge
- Collaborate with Drug Safety as necessary for issues pertaining to medical coding
- Attend and participate in project/company meetings including occasional off hour calls to coincide with our China or west coast colleagues
- Assist with assessment and decision making surrounding new technologies involving medical coding
- Other duties as assigned
Supervisory Responsibilities: Will directly supervise staff as they are hired into the organization
- Expertise with MedDRA and WHODrug
- Working knowledge of at least two coding solutions (e.g. dsNavigator or Medidata Rave Coder)
- Experience in managing junior staff and leading the review and communication of third- party vendor coding preferred
- Knowledge of medical terminology
- Ability to work in cross-functional team-oriented environments
- Understanding of ICH and regulatory environment as it pertains to data management
- Proficient computer skills, including Microsoft Office applications
- Excellent written, verbal and organizational skills
- Must be detail-oriented
- Experience with EDC databases required
- Knowledge of SDTM and CDASH principles desirable
- Experience in coding data for oncology clinical trials preferred
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Computer Skills : Efficient in Microsoft Word, Excel, and Outlook
Other Qualifications :
Travel: Occasional travel may be required
BeiGene USA, Inc. is an Equal Opportunity Employer welcoming diversity in our workforce. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring, and promotion practices are performed without regard to the above-listed items.