Project Data Manager

Syneos Health; India; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Syneos Health is seeking a Project Data Manager to lead end-to-end data management for assigned trials. You will coordinate DM/Operations with PMs, clinical monitoring, and other groups, ensuring timely delivery per contract and sponsor expectations.

Ideal candidates have 10+ years in Clinical Data Management, strong leadership, client-facing experience, and proficiency with Rave CDMS and Oracle Clinical. Oncology/pharma experience and CRO exposure are preferred.

Qualifications

• BA/BS in the biological sciences or Registered Nurse; equivalent experience accepted.
• 10+ years of Clinical Data Management experience.
• Leading studies with client-facing exposure.
• End-to-end CDM experience (Setup 4-5 years, Conduct, Closeout).
• Rave CDMS experience; oncology/pharma experience preferred.
• Experience with relational databases; familiarity with ICH/GCP.
• Strong project management and staff leadership skills.
• CRO experience preferred; Oracle/Inform systems knowledge.

Responsibilities

• Act as Functional Lead for Data Management and liaison with PM, Clinical Monitoring, and other groups.
• Coordinate the work of the DM/DO team on assigned projects.
• Ensure launch, delivery and completion of all DM activities per contract and SOPs.
• Provide project-specific training to internal and external audiences.
• Manage financial aspects including revenue recognition and scope changes.
• Monitor project progress and maintain TMF documentation; participate in audits.

Skills

Data management

Project management

Client facing

Team leadership

Rave CDMS

Oracle Clinical

Documentation & PM procedures

Communication

Education

BA/BS in biological sciences or RN

Tools

Rave CDMS

Oracle Clinical

Inform

Job description

Project Data Manager

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

Job Summary

Responsible for project management of all the data management services for the assigned projects. Ensures the contracted Data Management activities for projects are carried out by the Company in accordance with the executed contract and the Sponsor's expectations.

Core Responsibilities

• 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
• Coordinate the work of the assigned Data Management/Data Operations team
• 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 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
• Plan, manages and requests resources for assigned projects
• Develop and maintain project plans, specifications and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is complete 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
• Trains and mentors data management staff
• Prepares input for, and participates in proposal bid defense meetings
• Maintains proficiency in Data Management systems and processes through regular training
• Performs other work related duties as assigned. Minimal travel may be required (up to 25%)

Qualifications

• 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.
• Clinical data management experience or an equivalent combination of education and experience.
• Must have 10+ years of experience in Clinical Data Management.
• Must have experience in Leading studies & Client facing exposure
• End-to-end CDM experience (Setup 4-5 years, Conduct, Closeout)
• Must have Rave CDMS experience.
• Therapeutic Area: Preferred Oncology.
• Preferred experience with Phase 1, Clinical pharmacology
• Experience of Clinical Data Management practices and relational database management software systems.
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills.
• Contract Research Organization (CRO) experience preferred.
• Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. Effectiv