BioTalent
Overview
Direct message the job poster from BioTalent Position Summary Our client is seeking a talented and motivated
Contract Study Lead
with experience in oncology and a passion for advancing new cancer therapies. This individual will independently lead cross-functional study teams and provide oversight of clinical trials across the company’s pipeline. The role requires strong collaboration with internal and external stakeholders to ensure successful planning and execution of clinical programs. Key Responsibilities
Provide leadership to Study Execution Teams (SETs) to drive efficient trial initiation and on-time, on-budget completion in compliance with SOPs, FDA regulations, and ICH/GCP guidelines. Partner with cross-functional stakeholders to develop and review Requests for Proposal (RFPs), support vendor selection, and participate in bid defenses. Manage CROs and other vendors to ensure deliverables align with study and corporate objectives. Oversee development and review of essential clinical trial documents such as protocols, ICFs, CRFs, study manuals, and study plans. Track study budgets and contracts, including forecasting, invoice reconciliation, and management of work orders/change orders. Contribute to the implementation and oversight of clinical systems (e.g., CTMS, TMF, EDC, IRT). Review clinical data listings and tables, generate queries, and support data quality initiatives. Monitor site management activities in partnership with CROs, including reviewing monitoring reports and quality metrics. Support trial activities such as site selection, start-up, recruitment, protocol deviation management, and TMF review. Track study metrics and progress reports; identify risks proactively and implement mitigation strategies. Establish strong working relationships with internal stakeholders, external partners, and clinical sites. Deliver training on study protocols and trial conduct processes to investigators, site staff, vendors, and internal team members. Ensure inspection readiness at all times and participate in audits and regulatory inspections, as needed. Qualifications
Bachelor’s degree in life sciences or related field with 8–10 years of clinical research and drug development experience. Proven expertise in global clinical study management, vendor oversight, and application of FDA/ICH GCP regulations. Oncology clinical trial management experience required; early-phase or precision medicine trial experience strongly preferred. Strong organizational, analytical, and problem-solving skills with the ability to anticipate and address challenges. Self-motivated, detail-oriented, and comfortable working in a fast-paced, dynamic environment. Excellent communication and interpersonal skills, with a collaborative and solutions-focused mindset. Willingness to travel approximately 10%. Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Project Management and Science Industries: Biotechnology Research and Pharmaceutical Manufacturing We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Direct message the job poster from BioTalent Position Summary Our client is seeking a talented and motivated
Contract Study Lead
with experience in oncology and a passion for advancing new cancer therapies. This individual will independently lead cross-functional study teams and provide oversight of clinical trials across the company’s pipeline. The role requires strong collaboration with internal and external stakeholders to ensure successful planning and execution of clinical programs. Key Responsibilities
Provide leadership to Study Execution Teams (SETs) to drive efficient trial initiation and on-time, on-budget completion in compliance with SOPs, FDA regulations, and ICH/GCP guidelines. Partner with cross-functional stakeholders to develop and review Requests for Proposal (RFPs), support vendor selection, and participate in bid defenses. Manage CROs and other vendors to ensure deliverables align with study and corporate objectives. Oversee development and review of essential clinical trial documents such as protocols, ICFs, CRFs, study manuals, and study plans. Track study budgets and contracts, including forecasting, invoice reconciliation, and management of work orders/change orders. Contribute to the implementation and oversight of clinical systems (e.g., CTMS, TMF, EDC, IRT). Review clinical data listings and tables, generate queries, and support data quality initiatives. Monitor site management activities in partnership with CROs, including reviewing monitoring reports and quality metrics. Support trial activities such as site selection, start-up, recruitment, protocol deviation management, and TMF review. Track study metrics and progress reports; identify risks proactively and implement mitigation strategies. Establish strong working relationships with internal stakeholders, external partners, and clinical sites. Deliver training on study protocols and trial conduct processes to investigators, site staff, vendors, and internal team members. Ensure inspection readiness at all times and participate in audits and regulatory inspections, as needed. Qualifications
Bachelor’s degree in life sciences or related field with 8–10 years of clinical research and drug development experience. Proven expertise in global clinical study management, vendor oversight, and application of FDA/ICH GCP regulations. Oncology clinical trial management experience required; early-phase or precision medicine trial experience strongly preferred. Strong organizational, analytical, and problem-solving skills with the ability to anticipate and address challenges. Self-motivated, detail-oriented, and comfortable working in a fast-paced, dynamic environment. Excellent communication and interpersonal skills, with a collaborative and solutions-focused mindset. Willingness to travel approximately 10%. Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Project Management and Science Industries: Biotechnology Research and Pharmaceutical Manufacturing We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr