Principal Clinical Programmer (Rave EDC)

Syneos Health; India; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Syneos Health invites a Principal Clinical Programmer (Rave EDC) to join their Clinical Solutions team in India. You will lead complex Rave programming tasks, migration activities, and deliver high-quality programming across multi-study projects.

The role requires senior expertise in Rave, CFs, and CDMS tools, with leadership responsibilities on core deliverables. Ideal candidates have 10+ years of experience, strong problem-solving skills and ability to mentor junior programmers, while

Qualifications

• Must have experience in Rave Programming with Custom Functions Programming (Moderate to Complex). Overall 10+ years of experience is required.
• Migration exposure, Publish Check, PPC, TSDV, Study Build programming, SDBE Rave certification mandatory.
• Preferred Veeva CDMS experience.

Responsibilities

• Provides administration and technical support as subject matter expert on core packages including Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and related tools.
• Generates or maintains documentation for CRFs, databases, edit checks, imports/exports, listings and custom reports.
• Leads development activities for clinical programming projects and coordinates with project teams.
• Ensures high quality deliverables through senior review and participates in sponsor audits.

Skills

Rave Programming

Custom Functions Programming

Migration exposure

Publish Check

PPC

TSDV

Study Build programming

SDBE Rave certification

Veeva CDMS

Tools

Medidata

Rave

Oracle OC/RDC

Oracle Inform

SAS

Job description

Principal Clinical Programmer (Rave EDC)

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

• Must have experience in Rave Programming, Custom Functions Programming ( Moderate to Complex) with minimum 2+ years in CF. Overall 10+ years of experience is required.
• Must have Migration exposure, Publish Check, PPC, TSDV, Study Build programing, SDBE Rave certification mandatory.
• Preferred Veeva CDMS experience.
• Provides application administration and technical support as the subject matter expert on all core business packages, including but not limited to: Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and supplemental packages such as migration mentoring/review, reporting tools, custom functions, etc. Utilizes primary development tools and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
• 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.
• Monitors applications proactively for workflow alerts, system errors, performance issues and troubleshoot programming deliverable defects.
• Performs system integrations activities, application updates, and user acceptance testing.
• Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• Participates in and provides input at project review and departmental review meetings. Participates in bid defenses.
• Ensures high quality deliverables by providing senior review of 'program level'/multi-study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits.
• Reviews and provides input on study budgets, manages project level metrics, progress, and status, for large programs of studies from key sponsors. Monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Assists with the creation of change orders.
• Provides leadership, mentorship, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications and uses expanded technical skills to meet evolving project needs.
• Attends Quick Start Camps (QSCs) in the lead Clinical Programmer role for assigned studies.
• Provides leadership/oversight of five (5) to twenty (20) concurrent studies depending upon scope, similarity, program, and resourcing requirements. This may include the oversight of other lead programmers and