Manager, Clinical Data Science (Data Management)

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

The position is responsible for line managing, developing and being accountable for the Clinical Data

Scientists in their assigned team; client relationship management of assigned accounts; and for meeting

assigned operational targets including but not limited to quality, performance, utilization, retention, and

training. Ensures that contracted services of projects/program of projects are conducted by the Clinical

Data Science Team in accordance with the executed contract and client expectations. Supports Clinical

Data Science Business Development activities

Ensures project launch, conduct, and closeout activities are performed according to the client's

and the Company's contractual agreement. Ensures that all project-related Clinical Data Science

(CDSci) tasks are completed in accordance with internal and client quality standards, Syneos

Health SOPs, and all pertinent industry/regulatory guidelines and legal requirements. Ensures

project documentation is filed by project teams on an ongoing basis and the TMF is maintained in

an inspection ready state.

• Manages oversight of multiple projects ranging in size and complexity from single service studies

to multiple global projects within a program.

• Serves as primary escalation and relationship management point of contact for assigned client

accounts and projects. Responsible for escalation evaluation & solutions that can be solved at

Manager level, further escalating those that require additional leadership involvement.

• Accountable for financial health of assigned accounts. Oversees the functional lead financial

activity to proactively manage the scope, budget, and resources for their assigned projects.

Ensures the functional lead is appropriately and accurately forecasting future work.

• May review Clinical Data Science or other project documentation to ensure quality and

consistency across programs and teams.

• Guides functional CDSci leads to act as central stewards of clinical data quality, monitoring risks

through the holistic review of clinical and operational data, using high level knowledge of the

protocol, and considering the specific therapeutic area aspects of the protocol related to the data

collection requirements.

• Assists in the development of technology, tools or applications, for use across projects to detect

potentially unreliable data that may impact the validity of the trial results.

• Participates in submission of, analysis, and solutions for quality issues, CAPAs, and audit

findings.

Line Management and functional support of assigned staff. Interviews, onboards and trains new

staff as appropriate. Oversees professional development of direct reports by setting goals,

conducting performance reviews, evaluating and monitoring training needs, creating development

plans, mentoring, and coaching.

• Mentors staff in general team leadership skills, project management skills, internal Company

processes, business development skills, financial skills, and for project specific tasks.

• Manages the resources/workload of assigned team and projects, assigns tasks to team members,

manage billable and non-billable time, and subsequently monitors productivity/utilization,

timeliness, and quality.

• Maintains and evaluates functional lead and project progress. Works with CDSci’s to prepare for

and run Project Review Meetings for their assigned projects.

• Leads Clinical Data Science staff through client or regulatory audits. Plans for and participates in

client or regulatory audits.

• Represents Clinical Data Science at Business Development and client-related meetings. May

work with Business Development and the Proposal/Contracts groups to provide input to project

budgets and scope of work for client requested opportunities.

• May perform training for Clinical Data Science staff. Creates training materials as required.

• Participates in additional activities as assigned, such as (but not limited to): development of

departmental technologies, SOPs, processes, and procedures.

• Performs other work-related duties as assigned.

BA/BS in the biological sciences, computer sciences, mathematics, or data sciences and/or

related disciplines in the natural science/health care space. MS degree is preferred. In lieu of

degree, equivalent relevant work experience is considered.

• Strong knowledge of the drug development process and its impact on data quality, in particular

risk-based approaches, biometrics procedures, and workflows.

• Strong project management skills and knowledge of project management methodologies

• Ability to serve in a leadership role in Clinical Data Science including effective mentoring skills,

and the ability to deal effectively with clients and internal stakeholders.

• Excellent communication, presentation, interpersonal skills, both written and spoken, with an

ability to inform, influence, and persuade.

• Experience in Clinical Data Science practices and relational database management software

systems

• Demonstrated experience working within a team matrix structure.

• Demonstrated experience in making effective decisions and managing multiple priorities in a

highly dynamic environment.

• Possesses a positive attitude and works well with others.

• Knowledge of ICH/GCP regulatory requirements for clinical studies.

• Ability to travel as necessary (up to 25%)

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:

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.