Senior Clinical Data Scientist (Hybrid - Poland, Serbia, South Africa, Spain, CZ, Romania, Hung ...

Updated: Today
Location: Bloemfontein, FS, South Africa
Job ID:-OTHLOC-4265-2DH

Responsible for the 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.

• Hybrid role - 2 days at office per week
• Serves as Functional Lead for Clinical Data Science, acting as the primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups.
• Acts as central steward of clinical data quality, monitors risks through a holistic review of clinical and operational data, using high-level knowledge of the protocol and considering therapeutic area aspects to support comprehensive clinical data quality.
• Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis.
• Works with assigned project teams to communicate, address, troubleshoot, and resolve data related questions and recommends potential solutions; escalates issues that may impact patient safety and study analysis.
• Coordinates cross-functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables.
• Drives development of the clinical data acquisition plan and corresponding data flow diagram with the study team, assesses risks associated with protocol design, and sets parameters that could impact credibility and reliability of the trial results, aligning the data flow with the study protocol to meet regulatory and endpoint requirements.
• Drives development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact validity of the trial results; performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve data issues.
• Monitors and communicates project progress to the Sponsor and project team, using project status reports and tracking tools/metrics.
• Ensures launch, delivery, and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant SOPs, guidelines, and regulations.
• Reviews, maintains budget and identifies out-of-scope activities for Clinical Sciences; raises to PM to implement in required change order.
• Plans, manages, and requests Clinical Data Science resources for assigned projects.
• Coordinates the work of the assigned Clinical Data Science team.
• Develops and maintains 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 for necessary files.
• Participates in, and presents at internal, Sponsor, third party, and investigator meetings on behalf of Clinical Data Science responsibilities.
• Prepares input, and participates in proposal bid defense meetings and request for proposals.
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits.
• Trains and mentors new or junior team members.
• Maintains proficiency in Clinical Data Science 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%).

We comply with all obligations imposed by legislation in each country in which we operate, including the implementation of the EU Equality Directive and the Americans with Disabilities Act, and are committed to providing reasonable accommodations to assist employees or applicants in performing the essential functions of the job.