Senior Project Data Manager (ClinSpark)

Syneos Health India Private Limited; India; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Syneos Health India Private Limited seeks a Senior Project Data Manager to lead data management for ClinSpark-enabled projects. You will act as a project leader on stand-alone engagements and as Functional Lead on full-service programs, coordinating Data Management/Data Operations teams and ensuring milestones align with contracts and SOPs.

The role includes training internal and external stakeholders, managing project finances, and liaising with sponsors. Up to 25% travel may be required.

Qualifications

• Clinical data management experience or an equivalent combination of education and experience.
• Experience in Clinical Data Management practices and relational database management software systems.
• Technical knowledge like EDC programming and Rave web service to integrate data.
• Knowledge about CDISC (e.g. CDASH, SDTM, ODM-XML, Pinacle 21) Experience working with eSource data directly or eSource data capture system.
• Experience developing new processes and tools
• Experience designing and implementing data workflows
• Ability to evaluate, impr

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.
• 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 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.
• 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 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, acts as a subject matter expert.
• 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.
• Performs other work related duties as assigned.
• Minimal travel may be required (up to 25%).

Skills

Clinical data management

EDC programming

Rave web service

CDISC knowledge

eSource data

Data workflows

Mentoring staff

Education

BA/BS in biological sciences or RN

Tools

Rave

Relational databases

CDISC (CDASH, SDTM, ODM-XML, Pinnacle 21)

Job description

Senior Project Data Manager (ClinSpark)

Senior Project Data Manager (ClinSpark) 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 for projects are carried out by the Company in accordance with the executed contract and the Sponsor's expectations. The scope may include projects that are large and/or complex and/or with particular challenge.

Core 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. 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/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. 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 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, acts as a subject matter expert. 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. 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.
• Experience in Clinical Data Management practices and relational database management software systems.
• Technical knowledge like EDC programming and Rave web service to integrate data.
• Knowledge about CDISC (e.g. CDASH, SDTM, ODM-XML, Pinacle 21) Experience working with eSource data directly or eSource data capture system.
• Experience developing new processes and tools
• Experience designing and implementing data workflows
• Ability to evaluate, impr