Manager Clinical Database Programming (US/Remote)

Requisition Number: 3913

Position Title: Manager, Clinical Database Programming

External Description:

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 almost 2,500 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.   

Data Management is an ever growing and collaborative department! Our global team is a group of diverse individuals with wide-ranging experience within the industry. From start to finish, we are involved in clinical studies beginning with building the study database, to locking and delivering the final dataset for the project. Data Management reviews and ensures the clinical study data is of high quality for regulatory submissions.

The Data Management group is the perfect place to launch or further your career. Whether it is technical expertise, or coming from a clinical background, you’re able to hone and expand your skillset within our department. Spanning various roles from data support staff, database and SAS programmers, coders and functional leads, there is place for you!  

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

 
RESPONSIBILITIES:
Tasks may include but are not limited to:
 
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 3^rd 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 3^rd 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 3^rd 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

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Employment Type: Regular

Community / Marketing Title: Manager Clinical Database Programming (US/Remote)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Research Triangle Park (RTP), North Carolina US

CountryEEOText_Description: 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 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. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.