Clinical Study Lead- Small Sponsor

Overview

Regional lead overseeing oncology clinical trials from start-up to closeout.

Key Responsibilities

• ctms oversight
• tmf management
• data review
• vendor management
• risk management
• study metrics

Tasks

-Risk management: Proactively identify potential study risks, recommend mitigation strategies/solutions and facilitate discussions with internal and external stakeholders for implementation -Participate in implementation and oversight of clinical systems including but not limited to CTMS, TMF, EDC and IRT -Participate in other study activities as needed (e.g., site selection, start-up, recruitment, protocol deviation and TMF review) -Train investigators and site staff, vendors and team members on study protocol and trial conduct processes -In collaboration with SET, develop, review and facilitate Request for Proposals (RFPs), and contribute to bid defense meetings to select Contract Research Organizations (CROs) and other clinical vendors for the right strategic fit -Provide input and support in development and review of key study documents including protocols, ICFs, CRFs, study plans, Clinical Study Reports (CSR), as appropriate -Clinical data review of data listings and summary tables, including query generation -Manage various clinical vendors to ensure that project and corporate goals are achieved on time and within budget -Active management through resolution of site issues in collaboration with the other IDEAYA functional lines and CRO partner -Contribute to development and review key clinical documents (e.g., protocols, informed consent forms (ICFs), case report forms (CRFs), study reference manuals, study plans) -Review and track key study metrics and progress reports; anticipate complex obstacles and clinical trial challenges and implement creative solutions to achieve project goals and timelines -Support the Study Lead and Study Execution Team (SET) to ensure trials are initiated efficiently and completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations and ICH/GCP guidelines with minimal supervision -Ensure the clinical trial(s) are inspection ready at all times and participate in Quality Assurance and/or regulatory authority inspection audits, as needed -Site management (e.g., review of monitoring reports, recruitment, quality metrics) in collaboration with CRO -Serve as subject matter expert (SME) on various company/department initiatives and participate in the development, review and implementation of departmental SOPs and processes Fiscal and contracts management: oversee and manage vendor contracts, forecast financials in partnership with finance, reconcile invoices against accruals, ensure accuracy of all CRO/vendor work order and change order updates -Establish and maintain strong relationships with internal cross-functional teams, CROs and vendors, and clinical research site personnel for successful execution of clinical trials -Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial and conduct periodic TMF reviews/QCs, as needed

Requirements

• oncology
• clinical trials
• vendor mgmt
• fda/gcp
• 6+ years
• bachelor's

What You Bring

-Global trial experience is a plus -Detail-oriented and creative thinker with a passion for process optimization. -Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology. -Experience with site management and early phase trial management. -Bachelor's degree in life sciences or related discipline with 6+ years of experience in clinical and drug development. -Ability to analyze, triage problems, and propose solutions. -6+ years of industry experience- Prior monitoring experience -Early phase oncology trial management experience preferred, including precision medicine trials. -Ability to travel as required (up to 40%). -Results-oriented team player who enjoys collaborative work and building positive relationships. -Excellent organizational, analytical, and communication skills. -May require occasional domestic and international travel -Experience in interpreting and implementing FDA and ICH/GCP regulations and guidelines. -Oncology trial experience required

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Benefits

-Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Health Spending Account (HSA) -Transportation benefits -Critical Illness, Accident, and Hospital -Medical, dental & vision -Time Off/Leave (PTO, Vacation or Sick Leave) -Short and long-term disability -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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