Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post : Clinical Data Coder
Description
PURPOSE
Provide basic and some comprehensive data management expertise (defined as efficient and quality data management products) to Data Management (DM) team to meet sponsor and company needs. Perform Clinical Data Management and/or Coding activities, and may also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.
RESPONSIBILITIES
- Serve independently as a Clinical Data Coder (Coder) or in a leadership role in a specific DM area (e.g. Lead Coder) or DOC for one or more protocols with less than 5 operations staff, with guidance.
- Perform Medical Coding using MedDRA, WHO Drug and/or other relevant dictionaries as applicable.
- Validates/tests the coding set up and programming of coding reports; may also test databases, edit specifications or any related programming activities.
- May serve in the role of back-up to a lead coder.
- Conduct data review.
- Write and resolve data clarifications.
- May perform Serious Adverse Event (SAE) reconciliation activities.
- Understand and comply with core operating procedures and work instructions.
- Perform other duties as directed by the Lead Coder, DOC, DTL or Manager.
- Meet objectives as assigned.
- Develop and maintain good communications and working relationships with the DM team.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Thorough knowledge of Medical Terminology.
- Thorough knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD etc.).
- Excellent organizational, communication and leadership skills.
- Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems.
- Basic understanding of database technologies related to data management and coding.
- Ability to work on computer systems with ease and good working knowledge of computer programs.
- Excellent English written and oral communication skills.
- Knowledge of operating procedures and work instructions and the ability to apply them in practice.
- Able to present information effectively to individuals and small groups.
- Basic understanding of Drug Development Process and its relevance to Data Management.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
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Candidate Profile
Bachelor’s degree or educational equivalence in pharmacy, life sciences or related field or medical, nursing qualification with 1 year relevant experience or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive need to view computer screen for extended periods of time.
Additional Information:
Experience: 1-2 years
Location: Karnataka-Bangalore
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Data Coder
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