Single Sponsor Clinical Trial Manager – Local Study Manager

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

📋 Description

• Accountable for study initiation: prepares and completes UK regulatory submissions, including initial submissions and amendments, as well as the creation and customization of regulatory package documents.

• Responsible for overseeing site management, clinical monitoring with an emphasis on patient safety, regulatory compliance, Good Clinical Practice (GCP), and data integrity.

• Manages site interactions from feasibility assessment through to site closure.

• This may involve patient recruitment, investigator payments, or other related tasks.

• May take charge of identifying critical data and processes, assessing risks associated with protocol execution, and implementing risk mitigations related to the completion of the Risk Assessment and Categorization Tool (RACT).

• Reviews the study's scope of work, budget, and protocol content, ensuring the clinical project team (CRAs/Clin Ops Specialists) is informed of contractual obligations and parameters.

• Utilizes previous clinical experience, operational data, metrics, and reports to identify risks to the management of clinical trial deliverables.

• Escalates any risks to clinical trial management deliverables (timeline, quality, and budget) to the global manager, along with any activities and requests that fall outside of the contracted scope.

• Applies strategic thinking and problem-solving skills to propose and implement risk mitigations.

• Participates in and presents at key meetings, including the Kick-Off Meeting.

• Acts as a point of escalation for communications with investigator site staff and will be required to interact via phone or in person with principal investigators or other site personnel.

• This may involve accompanying CRA team members to sites for observation, motivation, or conflict resolution.

• Collaborates with other functional leaders to coordinate delivery handoffs and achieve expected study milestones such as site activation targets, enrollment objectives, and database lock timelines.

• Reviews and provides input on other functional plans.

• Responsible for the development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.

• Ensures that Clinical Trial Management Systems (CTMS), dashboards, and other systems are set up and accessible for the clinical team, including overseeing user acceptance testing (UAT) as necessary.

• Ensures that access and audit trail reviews are conducted as required.

• Coordinates initial and ongoing training for the study team regarding protocol specifics, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans, and study timelines.

• Oversees resource allocations for CRAs, site assignments, and the conduct of study team members, identifying risks to delivery or quality.

• Ensures the quality of clinical monitoring, central monitoring, and site management deliverables within a project, maintaining proper visibility of progress using approved systems and/or tracking tools.

• Reviews project oversight dashboards and other clinical trial systems (e.g., CTMS, Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards) to monitor site and patient activities, study team conduct, and verify that data reflects timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.

• Understands the monitoring strategy required for the study and, as needed, participates in developing the study risk assessment plan.

• Is accountable for ensuring their assigned clinical team members understand, comply with, and deliver according to the stated monitoring strategy, Clinical Monitoring Plan (CMP)/Site Monitoring Plan (SMP), and risk plans.

• Reviews the content and quality of site monitoring documentation (including monitoring calls, site visit reports, site letters, central monitoring reports, and relevant correspondence) to ensure they accurately reflect site management activities and convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.

• Documents requested revisions and approvals in the CTMS.

• Ensures that these deliverables are provided according to company and/or sponsor specifications, including adherence to delivery deadlines.

• Interacts with clients and other functional departments regarding clinical monitoring, central monitoring, and site management activities and deliverables.

• Provides status updates on clinical deliverables and risks to clients, project management, and leadership in accordance with departmental or study agreements.

• Offers solutions for obstacles in protocol execution and site management.

• Demonstrates an understanding of other functions' roles in achieving compliance and delivery in accordance with protocol, SOPs, ICH GCP, and country regulations.

• This may encompass data management, study start-up, patient recruitment, medical monitoring, pharmacovigilance, and Quality Assurance (QA).

• Supports Inspection Readiness for clinical trial management scope.

• Oversees CRAs and Clin Ops Specialists assigned to the study, routinely assessing study-specific process and training compliance, CMP compliance, and identifying emerging risks.

• May develop and support execution of corrective action plans at the site and study levels.

• Supports and completes activities to meet data cut and lock deadlines.

• Provides feedback to line managers on staff performance, highlighting strengths as well as areas for improvement.

• May be assigned to larger, more complex trials.

⛳️ Requirements

• Bachelor’s degree or RN in a related field or an equivalent combination of education, training, and experience.

• Proven ability to lead and align teams in achieving project milestones.

• Demonstrates capability to operate in an international environment.

• Exhibits expertise in site management and monitoring.

• Preferred experience with risk-based monitoring.

• Demonstrates understanding of clinical trial management financial principles and budget management.

• Knowledge of Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Must exhibit strong computer skills.

• Good communication, presentation, and interpersonal skills with project teams and sites.

• Strong conflict resolution skills.

• Demonstrates the ability to apply problem-solving techniques to resolve complex issues and employs a risk management approach to identify and mitigate potential threats to the successful conduct of a clinical research project.

• Exhibits critical thinking to ascertain the cause and appropriate solutions in identifying issues.

🏝️ Benefits

• We are passionate about developing our people through career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition and total rewards program.

• We are committed to fostering an inclusive culture – where you can authentically be yourself.