Principal Clinical Programmer

3 weeks ago


Remote, India Syneos Health Clinical Full time

**Description**

**Principal Clinical Programmer**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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 SUMMARY**:
**JOB RESPONSIBILITIES**:

- 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
- 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 their associated studies.
- Manages project resources, proactively alerting management of delivery and resourcing needs.
- Supervises the implementations of upgrades and new modules of remotely hosted vendors, acquiring all documentation and storing in the relevant areas.
- Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.
- Contributes towards the update of standard operating procedures and work instructions in line with department and company process and policy
- As required, oversees program level clinical programming operations by providing supervision for a team of clinical programmers. Responsibilities may include professional development performance appraisals, and employee advising for junior staff. Assigns project work and reviews workload for all direct reports. Manages staff development by establis



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