Senior Clinical Data Scientist (2nd Shift - 2 PM to 11 PM IST)
Syneos Health India Private Limited
IndiaremotePosted 28 days ago
S
Skill Required
Clinical-Data-ScienceClinical-Data-ManagementLife-SciencesHealthcare-AnalyticsBiometricsSenior-Medical-Data-ScientistSenior-Data-Scientist-In-Clinical-TrialsClinical-Data-ScientistSenior-Clinical-Data-Management-SpecialistSenior-Clinical-Data-ManagerSenior-Data-Scientist-In-BiopharmaData ScientistanalyticalObservabilitybuildingdesignAgileandFulltime
Key highlights
- Requires 12 years of experience in Data Management/Data Science including 4 years of project management.
- Career development and progression, peer recognition and total rewards program are part of the benefits package.
- Knowledge of ALCOA++ data quality principles is a key requirement.
- Travel up to 25% may be required for the role.
Role overview
The Clinical Data Science Lead will manage end‑to‑end coordination of cross‑functional data collection, cleaning, and quality assurance for clinical studies, acting as the primary liaison between Clinical Data Science and other project functions while ensuring compliance with contractual, regulatory, and SOP requirements.
Responsibilities
- Responsible for end‑to‑end coordination of cross‑functional data collection and cleaning activities to ensure clinical study data deliverables are fit for purpose and align with the executed contract and sponsor expectations and timelines.
- Serve as Functional Lead for Clinical Data Science including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups.
- Act as central steward of clinical data quality, monitoring risks through a holistic review of clinical and operational data, using high level knowledge of the protocol, taking into account specific therapeutic area aspects of the protocol related to the data collected and aligning with cross‑functional operational plans to drive comprehensive clinical data quality.
- Ensure required data elements and corresponding data quality oversight steps are identified to support the defined study analysis.
- Work with assigned project teams to communicate, address, troubleshoot and resolve data related questions and recommend potential solutions; escalates issues that potentially impact patient safety and study analysis.
- Coordinate cross‑functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables.
- Drive the development of the clinical data acquisition plan and corresponding data flow diagram with the study team, assess risks associated with protocol design, study set parameters that could impact credibility and reliability of trial results, and align data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements.
- Drive the development of analytical tools, utilize analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results.
- Perform analytic reviews as defined in scope of work and data acquisition plan, identify root cause to systematically resolve data issues.
- Monitor and communicate project progress to Sponsor and project team including use of project status reports and tracking tools/metrics.
- Ensure launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
- Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order.
- Plan, manage, and request Clinical Data Science resources for assigned projects.
- Coordinate the work of the assigned Clinical Data Science team.
- Develop and maintain project plans, specifications, and documentation in line with SOP requirements.
- Maintain documentation on an ongoing basis and ensure that all TMF filing is up to date for necessary files.
- Participate in, and present at internal, Sponsor, third‑party, and investigator meetings on behalf of clinical data science responsibilities.
- Prepare input, and participate in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities.
- Plan for and create necessary documentation to support internal and external audits; participate in such audits on behalf of clinical data science responsibilities.
- Train and mentor new or junior team members.
- Maintain proficiency in Clinical Data Science systems and processes through regular training; may attend/represent the company at professional meetings/conferences.
- Perform other work‑related duties as assigned. Minimal travel may be required (up to 25%).
Requirements
- BA/BS in the biological sciences, computer sciences, mathematics, or data sciences and/or related disciplines in the natural science/health care space. MS degree is preferred. In lieu of degree, equivalent relevant work experience.
- Clinical Data Science experience or an equivalent combination of education and experience.
- Twelve (12) years of experience in Data management, Data Science including four (4) years of project management experience.
- Experience in Clinical Data Science practices and relational database management software systems.
- Strong knowledge of the drug development process and its impact on data quality, in particular risk‑based approach, biometrics procedures, workflows.
- Aptitude for understanding analytic modeling methods such as regression, classification and clustering.
- Strong project management skills and knowledge of project management methodologies.
- Demonstrated staff leadership skills.
- Knowledge of ALCOA++ data quality principles.
- Strong experience with protocol interpretation, data collection and data cleaning specification development.
- Experience with data analysis/data review and visualization tool sets including but not limited to Python, R, Spotfire, SAS.
- Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences.
- Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
- Effective oral and written communication and 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.
Nice to have
- Strong analytical skills and knowledge of Artificial intelligence /machine learning methodologies (preferred).
Benefits
- Career development and progression opportunities.
- Supportive and engaged line management.
- Technical and therapeutic area training.
- Peer recognition and total rewards program.
- Inclusive culture that encourages authenticity.
Additional details
- Syneos Health is a leading fully‑integrated life sciences services organization built to accelerate customer success.
- The Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs.
- Syneos Health has 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 over the past 5 years.
- The role may involve traveling up to 25% of the time.
- Additional information: tasks, duties and responsibilities are not exhaustive; equivalent experience may be considered; the company complies with the EU Equality Directive and the Americans with Disabilities Act.
- Originally posted on Himalayas.