- Assist with investigator recruitment activities and site feasibility tasks.
- Perform essential document collection, review, and maintenance activities.
- Act as site contact for study and site management issues.
Precision for Medicine
11 open remote positions
Precision for Medicine supports life sciences companies in the use of precision medicine by helping them design and execute clinical trials. They focus on biomarker-led strategies and have expertise in data science, clinical trial management, and laboratory services.
Open Positions
- Serves as the project physician and provides medical and scientific expertise to project teams.
- Ensures the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety.
- Participates in the strategic planning and execution of critical development programs for clients in Oncology/Haematology.
- Responsible for timely and quality delivery of site activation readiness, mitigating risks.
- Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
- Maintain project plans, trackers, and regulatory intelligence tools.
- Independently oversees study site management, ensuring patient safety and data quality.
- Manages site start-up procedures, including feasibility, regulatory submissions, and document review.
- Conducts site visits, prepares reports, and communicates with site personnel and project management.
- Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
- Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
- Identify potential study risks and propose solutions on how to mitigate them.
- Research, compile and analyse information on therapeutic area(s) contained in the clinical protocol.
- Undertake the delivery of data driven analysis and site outreach feasibility for pre and post award opportunities.
- Provide training on feasibility methods and platforms and ensure accuracy / quality of survey data.
- Support the vision of and commitment to continuous improvement in operational excellence across all activities.
- Lead the evaluation of business processes and workflows to identify opportunities for improvement or automation.
- Partner with cross functional leadership to prioritize improvement opportunities and support strategic initiatives.
- Prepare budgets, proposal text and re-bids to support RFP responses.
- Coordinate RFP development meetings with sales, operational review and finance teams.
- Ensure accuracy and quality control of budget and proposal text edits.
- Review, draft, negotiate and track a variety of legal agreements.
- Work closely with Clinical Operations study team.
- Ensure deliverables are in alignment with defined study timelines.
- Management and operational delivery of the clinical elements within a trial.
- Successful execution of assigned trials and ensuring completion of trial deliverables.
- Identify challenges to study timelines/deliverables and offer creative action plans.
- Serve as primary point-of-contact and primary escalation point to the client.
- Coordinate and oversees all functional services including external vendors to the established timeline and budget.
- Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality.