Job Summary:
The Senior Clinical Trial Manageris a senior leader accountable foroverall clinical study operations including CRO and vendor management, development of project plans, budget, and resource management.They will lead the development of study operational plans and provide input into other functional area plans and processes as needed. They will provide oversight of the CRO, vendors and sites as well as ensure compliance with GCP and regulatory guidelines. This position will work cross-functionally with clinical development, legal, finance, regulatory affairs, quality assurance, and IT, as needed.
Job Responsibilities:
• Performs job with minimal supervision
• Acts as the clinical operations representative in a variety of cross-functional teams
• Collaborates with the program Clinical Operations Lead to develop and manage study level timelines and budgets in accordance with corporate, department, and project goals, working closely with internal leadership and CROs
• Independently manage clinical study vendors
• Establish key deliverables and KPIs in management of CRO and vendors
• Collaborate with CRO to identify and develop training needs for site staff, CRAs, and vendors specific to the study protocol and processes, including presenting these at Investigator Meetings and Kick-off meetings
• Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments and CRO, as applicable
• Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
• Responsible for management and/or oversight of eTMF structure, plans and quality.
• Manage study activities including, but not limited to, investigator selection, drug supply projections, study start-up, subject recruitment & retention, data collection, and database locks, study drug accountability and study closeout.
• Actively contribute to technical and study design discussions, providing input toward clinical trial outlines, protocols, informed consent forms, and clinical study reports.
• Lead and/or collaborate with functional team members to draft/revise, finalize, and implement project plans, study-specific training, system builds, CRF designs, UATs.
• Identify issues and risks with cross functional teams and service providers; develop and present proposed solutions and provide oversight of timely resolution in a collaborative approach.
• Collaborate with data management (internal or CRO vendor) and CRAs to ensure data quality and compliance with data cleaning timelines
• May perform clinical data review of patient profiles, data listings and summary tables, including query generation
• Leads and/or contributes to department process improvements/initiatives and SOPs
• Provide direction and mentoring to junior team members.
• Escalate pertinent CRA performance and site compliance issues when necessary
• May have line management responsibilities
• Performs other duties as assigned by management
Education & Experience Requirements:
• Bachelor's degree required, preferably in the Life Sciences or equivalent
• Minimum of 8-10 years of experience in clinical operations is required
• Experience managing a CRO as well as a complex study in a previous Clinical Trial Manager (or equivalent) position is required
• Global Clinical Trial experience in Phase I-III
• Experience in Rare Disease required, cardiovascular a plus
• Inspection readiness and inspection experience is a plus
• Exceptional attention to detail and organizational skills
• Excellent communication (oral and written), analytical, and project management skills
• Ability todevelop and maintain strong, collaborative relationships with key internal and external stakeholders
• Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment
• Abilityto quickly learn and use technical applicationswith preferred experience usingsmart sheets/MS Excel or equivalent and the ability to managebudgetsand forecast
• Prior auditing experiencepreferred
• Priorexperience working as a Clinical Research Associate (CRA) preferred
• In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
• Team leadership experience within a cross-functional matrix environment
• Ability to travel formeetingsand conferencesnationally and globally,approximately 10%-15%
What we Provide:
• The base salary range for this role is $171,000-$189,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Atrium offers competitive compensation and benefits which include stock options, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and unlimited of time off including summer & winter breaks
• A commitment to learning and development which includes a variety of programming internally developed by and for Atrium employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
$171,000 - $189,000 a year
