Manager, Clinical Programming

Syneos Health, Inc.; Hyderabad; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Syneos Health in Hyderabad is seeking a Manager, Clinical Programming to lead clinical programming operations, mentor staff and ensure on-time deliverables in a fast-paced, regulated environment. You will oversee documentation and validation for CRFs and databases, ensuring audit-ready outputs and sponsor satisfaction.

In this role you will collaborate with sponsor teams, manage resources across projects, and travel up to 25% as required to support client programs and regulatory milestones.

Qualifications

• Bachelor’s degree; Master’s preferred.
• 9+ years of Clinical Data Management or Clinical Programming experience.
• Experience as Lead Clinical Data Manager or Lead Clinical Programmer.
• Experience drafting technical specifications for EDC and SAS.
• Customer facing experience preferred.
• Excellent communication and interpersonal skills; ability to manage multiple priorities.

Responsibilities

• Manages team level clinical programming operations and directs staff development.
• Assists in development of training materials for Technical Data Operations and delivers trainings.
• Generates and maintains documentation for CRFs, databases, coding, validation, and reports.
• Proposes hours for change orders and collaborates with management for approvals.
• Represents Technical Data Operations at project and departmental reviews.
• Ensures high quality deliverables through senior reviews and audits.
• Monitors budgets, metrics and project status across large studies.
• Travel as necessary (up to 25%).

Skills

Clinical programming

Team leadership

Stakeholder communication

Project management

Problem solving

Budget & forecasting

Travel up to 25%

Education

Bachelor's degree

Master’s degree preferred

Tools

EDC (Electronic Data Capture)

SAS

Microsoft Office

Job description

Manager, Clinical Programming

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Description

Manager, Clinical Programming (Technical Data Ops)

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.

Core 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 Technical Data Operations and delivers training to data operations department and others with needs for Technical Data ops Specialist information.
• Generates and maintains all required documentation including the development of specifications, coding, and/or 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 Technical 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 Technical Data Ops 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.
• 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

• Bachelor’s degree, Master’s degree preferred. In lieu of Bachelor’s degree, equivalent related education and experience.
• The ability to deal effectively with sponsors and internal customers at all levels.
• 9+ years of Clinical Data Management or Clinical Programming experience.
• Must have experience as Lead Clinical Data Manager or Lead Clinical Programmer.
• Experience with drafting technical specifications for EDC and SAS preferred.
• Customer facing experience preferred.
• 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
• Ability to travel as necessary (up to 25%)

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.