Manager, Clinical Data Science

Syneos Health/ inVentiv Health Commercial LLC; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Syneos Health in the United States is seeking a Manager, Clinical Data Science (Data Management) to lead and develop the CDS team across studies, ensuring quality and regulatory alignment. You will partner with clients and internal teams to manage data management deliverables, drive process improvements, and contribute to business development while mentoring staff.

The role requires strong project management, deep knowledge of data quality and drug development, and a track record of delivering

Qualifications

• BS in biological sciences, computer sciences, mathematics or data sciences.
• MS degree preferred; relevant experience considered in lieu of degree.
• Strong knowledge of drug development processes and data quality.
• Strong project management skills.

Responsibilities

• Lead and develop Clinical Data Science team.
• Manage client accounts and project relationships.
• Ensure on-time delivery, quality and regulatory compliance.
• Oversee TMF maintenance and documentation.
• Support business development and project budgets.

Skills

Strong data science and data manage

Project management

Education

BS in biological sciences / computer sciences / mathematics / data sciences

MS degree preferred

Job description

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