Manager, Clinical Programming - India

Flex and Oncology Clinical Research Private Limited; Ernakulam; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Worldwide Clinical Trials in India is seeking a senior leader to manage the Clinical Database Programming team. You will ensure efficient, accurate, and timely delivery of data management deliverables, overseeing performance, timelines, and cross‑functional coordination with sponsors and sites.

The role requires 8+ years in data management systems, SAS programming, and CDISC SDTM, with at least 2 years of management experience.

Qualifications

• Be educated to degree level or relevant experience.
• At least 2 years management experience.
• Have at least 8 years plus experience of Data Management Systems and Software.
• An understanding of CDISC SDTM standards.
• Experience of SAS programming language.
• 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.

Responsibilities

• Proactively manage and develop the performance of Clinical Database Programmers through performance management, capability, training and development to meet the needs of the business.
• To liaise with relevant staff to determine the allocation of tasks, to establish timelines, to report progress and any issues outstanding.
• To assist with assessing the technical merits and development of, and changes to, software applications and databases (both internal and 3rd party).
• To manage EDC development work allocated to the Clinical Database Programmers in order to achieve timely delivery.
• To review specifications for the set‑up and modification of project specific data entry software (including edit check specifications).
• Review validation plan for edit check and reconciliation check specifications.
• To configure database/eDC software (both internal and 3rd party) for the use of DM, sponsor and sites.
• To perform testing of databases and related applications according to IT and Data Management departmental SOPs, both for initial set‑up and maintenance.
• To run database upload programs and to process any error reports.
• To liaise with 3rd party vendors to resolve issues, implement changes to software.
• To liaise with Sponsors or their designates on matters associated with the transfer of electronic data to or from the company, as defined by the Director, Data Management.
• Develop and maintain database libraries in assigned applications.
• Be involved in ongoing planning, progress reporting, monitoring of systems and study metrics.
• Be involved in the development and technical leadership of new processes and implementation of new solutions.
• To support Data Management in the production and maintenance of system procedures and documentation in accordance with applicable SOPs.
• Assist with Quality Assurance and Audit requirements.
• Perform other duties as assigned.

Skills

Leadership

Communication

Data Management

SAS

CDISC SDTM

Education

Bachelor's degree in Life Sciences/Computer Science

Tools

SAS Software

Job description

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

To provide management and leadership of the Clinical Database Programming team; ensuring the efficient, accurate and timely management of Clinical Database Programming deliverables.

RESPONSIBILITIES

• Proactively manage and develop the performance of Clinical Database Programmers through performance management, capability, training and development to meet the needs of the business.
• To liaise with relevant staff to determine the allocation of tasks, to establish timelines, to report progress and any issues outstanding.
• To assist with assessing the technical merits and development of, and changes to, software applications and databases (both internal and 3rd party).
• To manage EDC development work allocated to the Clinical Database Programmers in order to achieve timely delivery.
• To review specifications for the set‑up and modification of project specific data entry software (including edit check specifications).
• Review validation plan for edit check and reconciliation check specifications.
• To configure database/eDC software (both internal and 3rd party) for the use of DM, sponsor and sites.
• To perform testing of databases and related applications according to IT and Data Management departmental SOPs, both for initial set‑up and maintenance.
• To run database upload programs and to process any error reports.
• To liaise with 3rd party vendors to resolve issues, implement changes to software.
• To liaise with Sponsors or their designates on matters associated with the transfer of electronic data to or from the company, as defined by the Director, Data Management.
• Develop and maintain database libraries in assigned applications.
• Be involved in ongoing planning, progress reporting, monitoring of systems and study metrics.
• Be involved in the development and technical leadership of new processes and implementation of new solutions.
• To support Data Management in the production and maintenance of system procedures and documentation in accordance with applicable SOPs.
• Assist with Quality Assurance and Audit requirements.
• 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

• Be able to demonstrate good written and verbal communication skills.
• Ability to demonstrate a methodical and logical approach to problem solving and the ability to learn new tasks quickly.
• Ability to work with close attention to detail.
• Be questioning about the validity of data being entered/extracted.
• Be hardworking and efficient.
• Possess good team working skills.
• Key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.
• The job holder must be computer literate and numerate with a willingness to adapt to various computer systems.

REQUIREMENTS

• Be educated to degree level or relevant experience.
• At least 2 years management experience.
• Have at least 8 years plus experience of Data Management Systems and Software.
• An understanding of CDISC SDTM standards.
• Experience of SAS programming language.
• 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.

The company reserves the right to amend this job description in consultation with the employee to reflect changes in its organisational structure or to the job itself in line with emerging business needs.

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.

This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.