Senior Data Coding Specialist - India

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

SUMMARY: Utilize standard and/or sponsor custom dictionaries to code Adverse Events, Medical and Surgical Histories, Medications and any other sponsor requested medical terminology required for projects. Ensure coding guidelines and company SOP’s are adhered to and dictionary versions / updates are maintained as appropriate for the project.  Back up to Manager Clinical Coding and Data Management as required.

RESPONSIBILITIES:

Tasks may include but are not limited to:

• As a priority, provide coding support for projects including:

  • Coding activities for Study start up on existing and new EDC databases

  • Input into the Data Management Plan, performing User Acceptance Testing, including review of Database Specifications and CRFs

  • Performing manual coding of medical and medication terms, generation and review of coding consistency reports for accuracy and submission of coding reports to internal Medical Monitor / peer review and for sponsor review at periodic time points specified for the project.

• Coordinate dictionary implementation and version updates for projects as applicable.

• Communicate effectively with Sponsors on general and project specific coding issues, as needed. 

• Ensure coding is performed and delivered consistently both internally and externally with the highest quality and timelines are met according to study requirements.

• Coordinate dictionary licence validation checks and Worldwide licence renewal process.

• Identify coding process and technology improvements, implement changes, monitor the outcome and recommend further action.

• Provide leadership/mentorship to support junior staff performing coding activities.

• Attend sponsor and team meeting as necessary.

• Maintain solid awareness of study coding budget and potential CIS/OOS issues related to coding for studies.  

• Provide regular updates to management regarding coding deliverables, metrics, coding issues, etc. as necessary.  

• Ensure clinical coding operations are conducted according to WCT SOP’s.

• Act as back up to Manager Clinical Coding and Data Management as required.

• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

• Must be computer literate and numerate with a willingness to adapt to various computer systems. It is essential that the job holder works with close attention to detail and to be questioning about the validity of the data being entered.

• Excellent time management and man management skills.  

• Ability to prioritize and manage multiple coding tasks and to prioritize workload accordingly with attention to detail.  

• Very good interpersonal and communication skills and the ability to operate effectively in a global work environment. 

REQUIREMENTS:

• Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience Trained/experienced in coding with industry standard dictionaries (e.g., MedDRA, WHO-DD)

• A minimum of 3 years of experience in clinical data coding or a related role within the pharmaceutical, biotechnology, or medical device industries. 

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.