Senior Project Data Manager – ClinSpark

🔥 23 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

📊 Data Scientist

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Manage all data management services for assigned projects • Act as Project Leader and primary Sponsor contact for contracted Data Management activities and deliverables on stand-alone projects • Act as Functional Lead for Data Management and primary internal liaison on full-service projects • Coordinate assigned Data Management/Data Operations teams • Ensure launch, delivery, and completion of Data Management activities and milestones according to contracts, SOPs, guidelines, and regulations • Provide project-specific training to internal and external audiences • Manage project finances, revenue recognition, scope changes, and internal project review participation • Monitor and communicate project/program progress using status reports, tracking tools, and metrics • Support and request resource management for assigned projects/programs • Develop and maintain project plans, specifications, and documentation • Maintain ongoing documentation and ensure TMF filing is up to date • Participate in and present at internal, Sponsor, third-party, and investigator meetings • Create documentation for and participate in internal and external audits • Train and mentor data management staff and act as a subject matter expert • Prepare input for and participate in proposal bid defense meetings • Maintain proficiency 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 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 of EDC programming and Rave web service to integrate data • Knowledge of CDISC, including CDASH, SDTM, ODM-XML, and Pinacle 21 • Experience working with eSource data directly or eSource data capture systems • Experience developing new processes and tools • Experience designing and implementing data workflows • Ability to evaluate, improve, and optimize operational processes • Experience managing data mapping activities • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills • 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 • 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 • Knowledge of ICH/GCP regulatory requirements for clinical studies, particularly requirements applicable to Clinical Data Management • Contract Research Organization (CRO) experience preferred • Minimal travel may be required (up to 25%)

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations, when appropriate, under the Americans with Disabilities Act