Clinical Trials Manager, Oncology or I & I

Overview:

MRTx is seeking a highly experienced  Clinical Trials Manager with experience in Ocology or I & I to lead the successful planning, implementation, and conduct of clinical trials across multiple oncology/non-oncology indications. Reporting to the Head of Clinical Operations, the Sr. Clinical Trial Manager, Clinical Operations will be responsible and accountable for development of operational program strategy and leading execution of First in Human through Phase III trials depending on program life cycle, representing clinical operations on cross functional Program Teams, and managing clinical operations team members to ensure adherence with overall study timelines, budget, quality ,and regulatory standards (ICH/GCP ,internal SOPs). This role will be supporting Phase I-III clinical trials , the ideal candidate will have experience in Oncology indications or I &I.  The CRA will have the ability to work Hybrid work arrangement with Boston office MRTx requires a 70% office presence. .Availability for approximately 30–40% travel is required for site visits, co-monitoring, investigator meetings, and select international activities.

Responsibilities:

• Accountable for delivery of assigned clinical program and study budgets, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives.
• Collaborate with the Medical Director and cross functional teams on the development, planning, and execution of clinical operations program strategy for multiple oncology/non-oncology indications.
• Represent Clinical Operations at cross functional program meetings.
• Lead and oversee execution of assigned clinical trials to ensure all trial deliverables are met according to established timelines, goals, budget, and quality standards.
• Manage the cross functional study management team and CRO/vendor(s) related to all aspects of clinical trial operations.
• Develop and execute Clinical Trial Operations Strategy and other operational, vendor management and oversight plans.
• Lead identification, RFP/bid defense, and selection of CRO/third party vendors
• Accountable for the development, management, and tracking of trial budget as well as accuracy of trial information; provide ongoing reporting and forecasting to finance.
• Manage and provide documented oversight of CRO and third-party vendors to ensure quality and adherence to ICH/GCP standards as well as established study timelines.
• Contribute to development of clinical documents including the clinical trial protocol, Investigator’s Brochures, Informed Consent Forms, responses to questions from IRBs and Ethics Committees. Contribute to clinical sections of IND summary documents, CTAs for initiation of studies ex-US, and responses to questions from regulatory authorities.
• Establish study timelines and ensure accurate tracking and reporting of study metrics.
• Mentor junior members of the team
• Collaborate with Head of Clinical Operations to define and monitor key performance indicators and departmental metrics, as well as identification of opportunities for process optimization, training needs, and procedures (SOPs, Work Instructions).
• Contribute to departmental resourcing and recruitment plans to ensure proper timing and allocation of resources to clinical studies to achieve study timelines and deliverables.
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, ICH/GCP, and local regulations.
• Represent clinical operations to external stakeholders including key opinion/thought leaders.
• Additional duties and responsibilities as required.

Qualifications:

• Bachelor's degree in health sciences or related field.
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  Minimum of 8-10 years of global clinical trial and program operations experience with at least 4 years of independent clinical trial management through all phases of clinical trial execution (Start-up, maintenance, closeout).
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  Demonstrated experience with developing clinical operations strategy and plans including site monitoring, risk mitigation plans, recruitment plans, and CRO/vendor oversight plans.
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  Experience with managing and demonstrating oversight of CROs, vendors, and consultants.
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  Experience with managing or mentoring employees directly.
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  Extensive knowledge and application of current FDA Regulations, ICH/GCP guidelines in clinical trials.
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  Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project/Smartsheet.
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  Outstanding ability to communicate in an open and clear manner, listening effectively and inviting response and discussion with internal partners and external service providers.
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  Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
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  Proficient in risk management to prevent and overcome complex safety and compliance related issues during clinical program implementation.
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  Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority.
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  Comfortable in a fast paced, results-driven, highly accountable environment with large potential impact.