Principal Project Data Manager

5-14 years
7 days ago
Job Description


Principal Project Data Manager

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:

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 arededicated 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 togetherdiversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities
. On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
. May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM)
. Development and adherence to standards across a program of projects
. Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program
. Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
. Provides project specific training to internal and external audiences as required
. Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
. Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
. Supports the management of resources on assigned projects/programs
. Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment
. Develops and maintains project plans, specifications and documentation in line with SOP requirements
. Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date
. Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
. Plans for and creates necessary documentation to support internal and external audits participates in such audits
. May participate in or lead Data Management/Operations process improvement initiatives
. May supervise/line manage others
. Participates in the development of departmental technologies, SOPs, processes, and procedures
. Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training.
. Prepares input for, and participates in proposal bid defense meetings
. Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business
. May represent Data Management/Data Operations in company-wide initiatives
. Performs other work related duties as assigned. Minimal travel may be required (up to 25%)


What we're looking for
. Progressively responsible work experience in line with the expectations of the role.
. BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
. Minimum 14 years of experience in Clinical Data Management.
. Minimum 5 years of Project Data Management Experience, Strong in Project Delivery.
. Must have experience in leading Global projects independently End to End.
. Preferred experience in Veeva EDC.
. Strong project management skills and knowledge of project management methodologies.
. Good Knowledge of Project Budget and Revenue Recognition
. Exceptional Communication skills
. Demonstrated staff leadership skills.
. Contract Research Organization (CRO) experience preferred.
. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
. Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
. Effective oral and written communication skills.
. Strong presentation skills
. Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
. Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
. Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
. Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management

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

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.

INC Research/inVentiv Health has become Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization. We are purpose-built for biopharmaceutical acceleration, creating better, smarter, faster ways to help clients navigate an increasingly complex marketplace. Our new business addresses today&#8217&#x3B;s market realities through clinical and commercial sharing expertise and data and insights to meet the needs of emerging and large global biopharmaceutical companies.