Clinical Trial Manager/Senior Clinical Trial Manager

Overview

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, ensuring studies are conducted in accordance with the protocol, SOPs, ICH-GCP and all applicable regulatory requirements.

What you'll do

• Serve as 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 at Investigator Meetings and Study Kick-off meetings.
• Generate potential site list from key stakeholders and drive the site feasibility process.
• Identify potential risks to enrollment targets based on feasibility analysis and sites' contracted commitments.
• Develop and finalize the country recruitment/retention strategy.
• Develop timely and effective communication and good working relationships with investigators and the study team to ensure effective and timely feasibility, site start-up, enrollment, maintenance and close-out.
• Lead internal clinical team meetings and set expectations for the clinical team of CRAs and CTAs.
• Address all CRA and site questions and maintain the Frequently Asked Questions (FAQ) log as appropriate.
• Support in planning and conducting investigator meetings.
• Review and/or approve 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 to ensure study timelines are met and quality deliverables are assured.
• Generate and utilize metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure the study is conducted per plan, and communicate issues to PM and CRAs as appropriate.
• Be responsible for eTMF implementation and management.
• Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action (CAPA) plans, and be accountable for implementation and timely closure.
• Assist sites, internal staff and CRAs with the preparation for GCP audits.
• Work closely with PM on 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 program, assume project management responsibility as needed.
• Support business development and marketing activities as appropriate.
• May negotiate site budgets and investigator contracts with support from the legal department and/or site contracts group.
• May review site visit reports and ensure monitoring (scheduling and scope) is executed per the 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.
• Perform other duties as assigned by management.

What you'll need

• Bachelor's degree or equivalent combination of education/experience in a science or health-related field.
• 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.
• Demonstrated mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, with the ability to implement.
• Working knowledge of clinical management techniques and tools.
• Direct work experience in a cross-functional environment.
• Proven experience in functional management, including delegating while fostering cohesive team dynamics.
• Proven experience in planning, risk management and change management.
• High level of integrity; must inspire and demand the highest standards from a professional and ethical perspective.
• Ability to lead and inspire excellence within a team.
• Ability to create an environment where employees have a sense of ownership that leads to increased 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 proven experience in pharmaceutical and/or device research.
• Demonstrated successful independent negotiation and conflict management strategies.

Nice to have

• Advanced degree.

Details

• Location: Remote, United States.
• 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.
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.