OncoBay Clinical is a full service CRO focusing on complex oncology indications including Immunotherapy and cellular therapies. We know that innovative research requires innovative operations and build that into our culture, systems and processes. Our culture values and rewards critical thinking and open dialogue about quality — and that goes far beyond sole reliance on tools and checklists. We have an infrastructure to enhance access to patients, and integrated technology to provide higher quality and faster access to results. We remain vigilant and consistent with the advice in FDA Guidance on Monitoring, which encourages a quality risk management approach to clinical trial design and operation, and discourages a one size fits all mentality.
Are you ready to think outside the box and drive results? OncoBay Clinical might be the next right step to build your career and to make a difference.
JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
- Acts as a primary liaison between the Company and the Customer to ensure timely study initiation, conduct, and closeout according to the Customer’s and the Company’s contractual agreement, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.
- Lead project team to ensure quality, timelines, and budget management, including ensuring quality of clinical monitoring and site management deliverables.
- Accountable for the financial performance of each assigned project, including reviewing study budgets, time, expenses, and invoices.
- Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
- Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
- Reviews study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, suspected scientific misconduct on other systematic errors that could impact data integrity and subject safety.
- Drives risk identification and risk monitoring strategy cross-functionally, ensures that appropriate risk monitoring tactics are written into the CMP, and is accountable for the clinical team’s understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP, and risk plans.
- Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
- Creates and maintains relevant Project Plans.
- Routinely reviews clinical systems, dashboards, and documentation (e.g., Site Assessment Reports) to oversee site and study team conduct and identify any risks to delivery or quality.
- Reviews the content and quality of site monitoring documentation to ensure they represent site management activities and conduct.
- May participate in Customer proposal development and bid defenses.
- In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings.
- Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
- May evaluate CRA competency to perform site assessments independently via sign-off visits according to company standards and process.
- Accountable for all project deliverables for each project assigned.
Location: Tampa, FloridaApply