Senior Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Acts as the clinical trial lead overseeing the planning, execution, and management of the operational aspects of clinical studies.

• Serves as the primary clinical liaison with clients.

• Collaborates with the Project Manager on monthly billing and management of clinical budgets.

• Creates study-related clinical documentation, including clinical plans, Informed Consent Form templates, study-specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides, and other training materials.

• Identifies and develops training requirements for Clinical Research Associates (CRAs) and third-party vendors related to the study, protocol, and practices, including presenting these at Investigator Meetings and Study Kick-off meetings.

• Compiles a potential site list from key stakeholders and leads the site feasibility process.

• Assesses potential risks related to enrollment targets based on feasibility analysis and the site’s contractual commitments.

• Develops and finalizes the recruitment and retention strategy for the country.

• Establishes timely and effective communication and fosters strong working relationships with investigators and the study team to ensure efficient feasibility, site startup, enrollment, maintenance, and closeout processes.

• Leads internal clinical team meetings and sets expectations for the clinical team of CRAs and Clinical Trial Assistants (CTAs).

• Addresses all CRA and site inquiries and maintains a Frequently Asked Questions (FAQ) log as necessary.

• Assists in planning and conducting investigator meetings.

• Reviews and/or approves investigational product release packages.

• Oversees, supports, and tracks all submissions and approvals to Competent Authorities and IRB/Ethics Committees in collaboration with regulatory departments as necessary.

• Develops clinical monitoring strategies to ensure study timelines are adhered to and quality deliverables are achieved.

• Generates and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to confirm that the study is conducted according to plan and communicates issues to the Project Manager and CRAs as required.

• Responsible for the implementation and management of the electronic Trial Master File (eTMF).

• Collaborates with the Project Manager, CRAs, and Quality Assurance to formulate any Corrective and Preventative Action Plans (CAPA) and is responsible for their implementation and timely resolution.

• Assists sites, internal staff, and CRAs in preparing for Good Clinical Practice (GCP) audits.

• Works closely with the Project Manager on project-specific resourcing challenges.

• Escalates relevant CRA performance and site compliance issues when necessary.

• Collaborates with data management and CRAs to ensure data quality and adherence to data cleaning timelines.

• Manages processes related to investigational product (IP), including drug accountability and reconciliation.

• In the absence of a cross-functional Project Manager for a particular program, the Clinical Trial Manager (CTM) will assume project management responsibilities as needed.

• Supports business development and marketing initiatives as appropriate.

• May negotiate site budgets and investigator contracts with assistance from the legal department and/or site contracts group.

• May review site visit reports and ensures that monitoring activities (i.e., scheduling and scope) are conducted per the monitoring plan.

• May be responsible for managing clinical vendors (e.g., labs, IP, patient diaries, home health care) in conjunction with the Project Manager.

• May perform clinical data reviews 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 an equivalent combination of education and experience in a science or health-related field. An advanced degree is preferred.

• At least 7 years of clinical research experience or demonstrated competencies for the role with substantial clinical monitoring experience.

• Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

• Exceptional communication and interpersonal skills to effectively engage with others in a team environment.

• Strong organizational skills, meticulous attention to detail, and a customer service-oriented attitude.

• Willingness 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.