Manager, Clinical Programming; DOTS​/EDC Build

Position: Manager, Clinical Programming (DOTS/EDC Build)
Location: Prakāshamnagar

Description

Manager, Clinical Programming (DOTS/EDC Build)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Job Responsibilities

Job Summary

Manages clinical programming operations. Manages support staff's operational deliveries and timeline adherence. Proactively monitors internally and externally hosted applications for performance and/or system errors.

Job Responsibilities

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…