Manager, EDC Programming (EDC Build, Specification & Testing)

Manages team level clinical programming operations by providing direct line management of departmental managers and non-management staff.

Line management responsibilities including professional development, performance appraisals and employee counseling for junior and management staff.

Assigns project work and reviews workload for all direct reports.

Manages staff by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level.

Resolves conflicts/priorities at the site level prior to making any recommendations to management.

Works with and advises subordinates on administrative policies and procedures, technical problems, priorities, and methods.


Assist in the development of training materials associated with Clinical Programming operations and delivers training to data operations department and others with needs for Clinical Programming information.


Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRF)s, database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports
Proposes hours need for change order related to clinical programming activities and works with senior/project management to gain approval.


Attends and represents Data Operations at project review, and departmental review meetings.


Ensures high quality deliverables by providing senior review of core deliveries for accuracy, performing in-progress audits, and attending sponsor audits.


Prepares activity, resource and progress reports regarding the clinical programming group for upper management review.


Participate in the development of project specific software applications and ensures company documentation and computer system validation requirements are adhered to.


Utilizes primary development tools including Oracle RDC, Oracle Inform, Medidata Rave, and/or SAS and other supporting tools.


Reviews and provides input on study budgets, manages study level metrics, progress and status, including large programs of studies for key sponsors.

Ensures project timelines and scope of work are achieved as on-time, high quality deliveries.


Maintains departmental site-level utilization/realization and project-level targets at a profitable level and ensures regular accurate review of backlog and forecasting

Qualifications

What we re looking for
Bachelor s degree, Master s degree preferred.

In lieu of Bachelor s degree, equivalent related education and experience.

10+ Years of industry experience from Clinical programming (EDC build) and EDC specification testing from data management side is preferred

Min 2 Years of experience into people management & should have managed a team of 12 to 18 people.

Experience on mentoring & coaching team members is required.

Major responsibility will involve line management & no hands-on delivery is expected.

Exp on any Therapeutic areas is okay.

Experience on client engagement & escalation management, performance management is required.

The ability to deal effectively with sponsors and internal customers at all levels.


Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.


Demonstrated experience in managing multiple priorities in a highly dynamic environment
Experience working in a matrix-structured environment is preferred
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail
Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred.


Ability to travel as necessary (up to 25%)