Principal Clinical Data Scientist- Data Management

Principal Clinical Data Scientist- Data Management

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

Summary

The Principal Clinical Data Scientist provides strategic and operational leadership for end-to-end clinical data collection, cleaning, and quality oversight across complex clinical studies. This role serves as the functional lead for Clinical Data Science, ensuring clinical data deliverables are fit for purpose, compliant with regulatory and contractual requirements, and aligned with sponsor expectations and study timelines. The position partners cross-functionally to drive data quality, risk mitigation, analytics innovation, and timely delivery of clinical data milestones.

Responsibilities

• Serve as the Data Management Functional Lead for Clinical Data Science on complex, multi-scope clinical projects and act as the primary liaison between Clinical Data Science, Project Management, Clinical Monitoring, and other functional groups.
• Develop Data Management Plan, Communicate, troubleshoot, and resolve complex data-related issues; recommend solutions and escalate issues impacting patient safety, data integrity, or study analysis

• Act as the central steward of clinical data quality through holistic review of clinical and operational data using detailed protocol and therapeutic area knowledge.

• Ensure required data elements and corresponding data quality oversight steps are identified to support defined study analyses.

• Coordinate cross-functional data cleaning activities to meet quality standards, timelines, and contractual obligations.

• Communicate, troubleshoot, and resolve complex data-related issues; recommend solutions and escalate issues impacting patient safety, data integrity, or study analysis.

• Develop Clinical Data Acquisition Plans and data flow diagrams for complex studies and align data flow with study protocols, regulatory requirements, and study endpoints.

• Assess risks related to protocol design, program-level strategies, and study parameters that may impact data credibility and trial reliability.

• Design and drive development of analytical tools and dashboards to identify potentially unreliable or high-risk data.

• Perform analytic reviews as defined in the scope of work and data acquisition plans; identify root causes and implement systematic resolutions.

• Demonstrate understanding of advanced technologies and assess their applicability to individual studies or programs.

• Monitor and communicate project progress using status reports, tracking tools, and metrics to Sponsors and internal teams.

• Ensure launch, delivery, and completion of Clinical Data Science milestones in compliance with contracts, SOPs, guidelines, and regulatory requirements.

• Collect and analyze metrics to support continuous process improvement initiatives.

• Review and manage Clinical Data Science budgets, identify out-of-scope activities, and initiate change orders through Project Management.

• Plan, manage, and allocate Clinical Data Science resources and coordinate the work of assigned team members.

• Develop and maintain project plans, specifications, and documentation in compliance with SOP requirements.

• Maintain ongoing documentation and ensure Trial Master File (TMF) completeness and accuracy.

• Participate in and present at internal, Sponsor, investigator, and third-party meetings.

• Provide input to proposals, bid defenses, and RFP responses and promote new Clinical Data Science business opportunities aligned with Sponsor strategies.

• Prepare documentation for and participate in internal and external audits.

• Train and mentor junior team members and maintain proficiency in Clinical Data Science systems through ongoing training.

• Perform other duties as assigned.

Qualifications

Education

• Bachelor's degree in Biological Sciences, Computer Science, Mathematics, Data Science, or related discipline required.

• Master's degree preferred.

• Equivalent relevant experience may be considered in lieu of degree.

Experience

• Minimum of 10 years of experience in Clinical Data Management and/or Clinical Data Science.

• At least 5 years of project management experience.

• Experience with Clinical Data Science practices and relational database management systems.

• In-depth knowledge of the drug development lifecycle, including risk-based data quality approaches and biometrics workflows.

Skills & Knowledge

• Expertise in protocol interpretation, data collection strategies, and data cleaning specification development.

• Knowledge of ALCOA++ data quality principles.

• Knowledge of medical terminology, clinical trial data, and ICH/GCP regulatory requirements.

• Proficiency with Microsoft Word, Excel, PowerPoint, email, and Windows-based applications.

• Strong leadership, communication, organizational, and time-management skills.

• Ability to manage multiple priorities in a fast-paced, dynamic environment.

• Ability to work independently and collaboratively across multidisciplinary teams.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

$95,000.00 - $175,700.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

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.