Description

Senior Principal Clinical Programmer

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

Qualifications / Expectations:

• 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. (Senior LT stakeholder management).

• 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. (Good project management skills).

• Experience working in a matrix-structured environment is preferred.

• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail.

• Python / SAS and clinical data expertise.

• Sound knowledge of medical or safety review dashboards or listings.

• SDTM and Veeva data knowledge is preferred.

• No hands-on required, but should have a good understanding of the systems, tools, processes, data flows, and technicalities involved in carrying out system/tool migrations.

• Experience in mentoring others in clinical trial process.

• Ability to read, write, speak and understand English.

Responsibilities:

• Provides clinical programming technical support and expertise across the DM/Clinical Programming function and other departments as needed.

• Provides application administration and technical support as the subject matter expert on all core business packages, including but not limited to: Veeva, SAS, Python, Spotfire, 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 troubleshoots programming deliverable defects.

• Performs system integration 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. May act as primary customer interface representing the department at client meetings; may present status updates at Senior Management meetings.

• 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.

• Assists with management of application vendors and serves as an initial escalation contact. Monitors vendor service level agreements (SLAs) and reports metrics to upper management.

• 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

• Proposes and leads the development of process improvements, clinical programming tools for standardization and efficiency, and the development of new concepts, technologies and products to meet emerging customer needs.

• 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 establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level. Resolves conflicts/priorities at the program level prior to making any recommendations to management. Advises on administrative policies and procedures, technical problems, priorities, and methods.

• Performs other work-related duties as assigned.

• Minimal travel may be required

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.

Summary

Serves as lead Clinical Programmer to manage and support all functional tasks and project deliverables from single study assignments to large programs of studies. Manages multiple project timelines and deliverable whilst leading less experienced programmers. The Senior Principal Clinical Programmer demonstrates a high degree of independence, technical skills and ability to influence the team and clients to get results with minimal to no supervision, may determine the overall strategy for the clinical programming tasks across a program; identifies trends across projects, and takes appropriate action to replicate positive results and mitigate negative ones. A Senior Principal Clinical programmer demonstrating a high degree of expertise in developing, and validates applications supporting data capture and processing and may serve as subject matter expert, supports clinical programming and Data Management staff for Electronic Data Capture (EDC), reporting, and processing tools. Proactively monitors internally and externally hosted applications for performance and/or system errors. Supports projects and applications externally. Manages external application vendor issues, integrations, and implementations. May have supervisory responsibility and/or oversight for a team of lead clinical programmers within a program.