Senior Clinical Trial Manager

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) • Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings • Generate potential site list from key stakeholders and drive site feasibility process • Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment • Develop and finalize the country recruitment/retention strategy • Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures • Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs • Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate • Support in planning and conducting investigator meetings • Review and/or approve of IP release packages • Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable • Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables • Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate • Responsible for eTMF implementation and management • Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure • Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits • Work closely with PM for project-specific resourcing issues • Escalate pertinent CRA performance and site compliance issues when necessary • Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines • Manage processes for investigational product (IP) including drug accountability and reconciliation • When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed • Support business development and marketing activities as appropriate • May negotiate site budget and investigator contract with support from the legal department and/or site contracts group • May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan • May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM • May perform clinical data review of patient profiles, data listings and summary tables, including query generation • May have line management responsibilities • Performs other duties as assigned by management

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred • Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) • Excellent communication and interpersonal skills to effectively interface with others in a team setting • Excellent organizational skills, attention to detail, and a customer service demeanor • Ability to travel domestically and internationally including overnight stays

🏖️ Benefits

• discretionary annual bonus • health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation