Senior Clinical Data Co-ordinator - India

Worldwide Clinical Trials; Thiruvananthapuram; On-site; INR 800,000 - 1,500,000; Full time

Job summary

Worldwide Clinical Trials in India is seeking a dedicated Data Manager to coordinate and perform processes involved in the configuration, maintenance and validation of databases and database systems and associated applications.

You will train and mentor staff, review specifications, develop SAS programs for data management, and liaise with vendors and sponsors to ensure accurate data transfers, quality assurance and documentation in line with SOPs.

Qualifications

• Be educated to degree level or relevant experience
• At least 5 years 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
• 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

Responsibilities

• To liaise with relevant staff to determine the allocation of tasks, to establish timelines, to report progress and any issues outstanding.
• To assist in training and mentoring Clinical Database Programmers in the configuration of databases and development, testing and running of SAS programs.
• To assist in training and mentoring Data Management staff in the specification of databases and SAS programs.
• 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.
• Develop, test and run SAS programs for clinical data management. This includes programs for data validation and reconciliation checks, data listings and data transfers.
• 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.
• 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.

Skills

Written & verbal communication

Attention to detail

Logical problem solving

Teamwork

Willingness to learn

Education

Degree level education

CDISC SDTM knowledge

Tools

SAS programming

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.

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 co-ordinate and perform processes associated with the configuration, maintenance and validation of databases and database systems and associated applications.

Responsibilities

Tasks may include but are not limited to:

• To liaise with relevant staff to determine the allocation of tasks, to establish timelines, to report progress and any issues outstanding.
• To assist in training and mentoring Clinical Database Programmers in the configuration of databases and development, testing and running of SAS programs.
• To assist in training and mentoring Data Management staff in the specification of databases and SAS programs.
• 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.
• Develop, test and run SAS programs for clinical data management. This includes programs for data validation and reconciliation checks, data listings and data transfers.
• 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.
• 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.
• Be able to demonstrate a methodical and logical approach to problem solving and the ability to learn new tasks quickly.
• Be able 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 5 years 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.

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.