Clinical Trial Manager/Senior Clinical Trial Manager

Position Summary:

Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.

Essential functions of the job include but are not limited to:

• 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, including 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 lists from key stakeholders and drive the site feasibility process
• Identify potential risks to enrollment targets based on feasibility analysis and site contracted commitments
• Develop and finalize country recruitment and retention strategies
• Develop timely and effective communication and working relationships with investigators and study teams to ensure effective feasibility, site start-up, enrollment, maintenance and close-out procedures
• Lead internal clinical team meetings and set expectations for clinical teams of CRAs and CTAs
• Address CRA and site questions and maintain FAQ logs as appropriate
• Support planning and conducting investigator meetings
• Review and/or approve investigational product release packages
• Oversee, support and track submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments
• Develop clinical monitoring strategies to ensure study timelines and quality deliverables
• Generate and utilize metric reporting, including CTMS, DM query trends and outstanding monitoring reports, to ensure studies are conducted according to plan
• Be responsible for eTMF implementation and management
• Collaborate with PM, CRAs and QA to develop Corrective and Preventative Action Plans and ensure timely implementation and closure
• Assist sites, internal staff and CRAs with preparation for GCP audits
• Work closely with PM on project-specific resourcing issues
• Escalate 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 investigational product processes, including drug accountability and reconciliation
• Assume project management responsibilities as needed when a cross-functional PM is not assigned
• Support business development and marketing activities as appropriate
• Negotiate site budgets and investigator contracts with support from legal or site contracts teams as needed
• Review site visit reports and ensure monitoring is executed according to the monitoring plan as needed
• Manage clinical vendors in conjunction with PM as needed
• Perform clinical data review of patient profiles, data listings and summary tables, including query generation, as needed
• Have line management responsibilities as needed
• Perform other duties as assigned by management

Qualifications:

Minimum Required:

• Bachelor’s degree or equivalent combination of education and experience in a 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

Preferred:

• Advanced degree

Other Required:

• Experience with Microsoft Office products, including Outlook, Word, Excel and PowerPoint
• Excellent communication and interpersonal skills
• Excellent organizational skills, attention to detail and a customer-service demeanor
• Ability to travel domestically and internationally, including overnight stays

Competencies:

• Mastery of ICH-GCP, relevant Precision SOPs and regulatory guidance, with the ability to implement them
• Working knowledge of clinical management techniques and tools
• Direct experience in a cross-functional environment
• Experience in functional management and delegation while fostering cohesive team dynamics
• Experience in planning, risk management and change management
• High integrity and commitment to professional and ethical standards
• Ability to lead and inspire excellence within a team
• Ability to create an environment that fosters employee ownership and increases productivity and efficiency
• Results-oriented, accountable, motivated and flexible
• Excellent time management, negotiation, critical-thinking, decision-making, analytical and interpersonal skills
• Excellent presentation, verbal and written communication skills
• In-depth experience in pharmaceutical and/or device research
• Successful independent negotiation and conflict-management strategies

Compensation:

The reasonable compensation estimate for this role is $110,700–$200,900 USD. The role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.