Senior Project Data Manager – ClinSpark

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee all data management services for designated projects

• Serve as the Project Leader and main Sponsor contact for contracted Data Management tasks and deliverables on independent projects

• Function as the Functional Lead for Data Management and primary internal liaison on full-service projects

• Coordinate the assigned Data Management/Data Operations teams

• Ensure the initiation, delivery, and completion of Data Management tasks and milestones in accordance with contracts, SOPs, guidelines, and regulations

• Provide project-specific training to both internal and external audiences

• Manage project finances, revenue recognition, scope modifications, and participation in internal project reviews

• Track and report on project/program progress utilizing status reports, tracking tools, and metrics

• Support and request resource management for assigned projects/programs

• Develop and maintain project plans, specifications, and documentation

• Ensure ongoing documentation is maintained and TMF filing is current

• Participate in and present at internal, Sponsor, third-party, and investigator meetings

• Create documentation for and take part in internal and external audits

• Train and mentor data management personnel and serve as a subject matter expert

• Contribute to and participate in proposal bid defense meetings

• Maintain expertise in Data Management systems and processes through regular training

• Attend or represent the company at professional meetings/conferences as needed

• Perform other related duties as assigned

⛳️ Requirements

• BA/BS in biological sciences or related fields within the natural sciences/health care sector or Registered Nurse

• Equivalent relevant work experience considered in lieu of a degree

• Experience in clinical data management or a comparable mix of education and experience

• Familiarity with Clinical Data Management practices and relational database management software systems

• Technical expertise in EDC programming and Rave web services for data integration

• Knowledge of CDISC standards, including CDASH, SDTM, ODM-XML, and Pinnacle 21

• Experience with eSource data directly or through eSource data capture systems

• Proven experience in developing new processes and tools

• Background in designing and executing data workflows

• Ability to assess, enhance, and streamline operational processes

• Experience managing data mapping efforts

• Strong project management abilities and understanding of project management methodologies

• Demonstrated leadership skills in staff management

• Direct experience with Oracle Clinical, Rave, or Inform systems

• Familiarity with medical terminology, clinical data, and ICH/Good Clinical Practices

• Proficient in navigating MS Windows, Word, Excel, PowerPoint, and email applications

• Strong oral and written communication abilities

• Exceptional presentation skills

• Excellent organizational, planning, and time management skills with the capability to multitask under tight deadlines while maintaining attention to detail

• Ability to adapt to changes and work independently as well as part of a multidisciplinary team

• Skilled in making effective decisions and managing multiple priorities in a fast-paced environment

• Knowledgeable about ICH/GCP regulatory requirements for clinical studies, particularly those pertaining to Clinical Data Management

• Preferred experience in a Contract Research Organization (CRO)

• Minimal travel may be necessary (up to 25%)

🏝️ Benefits

• Opportunities for career development and advancement

• Supportive and engaged line management

• Training in technical and therapeutic areas

• Peer recognition programs

• Comprehensive total rewards program

• Inclusive workplace culture

• Reasonable accommodations provided when appropriate under the Americans with Disabilities Act