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Job Overview:
The Clinical Trial Manager II owns the clinical delivery and operational oversight of clinical research trials within the core project team. The CTM II collaborates with project managers and other functional leads to deliver clinical and start-up activities within budget and contract, ensuring quality, compliance and meeting country-specific commitments.
While the role may occasionally support larger, more complex trials under the guidance of a Senior Clinical Trial Manager, it is generally expected to manage most studies independently and comprehensively.
Summary of Responsibilities:
End-to-end oversight of start-up and clinical responsibilities—from site identification through to database lock—through proactive management of project scope, timelines, milestones, and budget.
Ensure start-up and clinical project plans address identified risks while adhering to professional standards, SOPs, client, and regulatory requirements.
Proactively identify and address start-up and clinical project, financial, and quality risks by applying comprehensive risk management strategies and ensuring compliance, including tracking within applicable systems.
Responsible for financial aspects of clinical and start-up activities, including revenue forecasting, adherence to contracted scope, and oversight of scope modifications.
Ensure project team awareness and tracking of Key Project Indicators (KPI) for any client-specific start-up and clinical metrics.
Ensure and plans for start-up and clinical resources with accurate projections for the resourcing teams.
Develop and implement the site activation and recruitment strategy in collaboration with project teams.
Lead and oversee site identification and site selection.
Oversight of Informed Consent Form development and translations.
Oversight of essential document creation and collection, including insurance.
Oversight of the development, negotiation, and execution of Clinical Trial Agreements (CTA), including site budgets.
Lead the end-to-end process of regulatory/ethics committee submissions, approvals, and tracking.
Ensure clinical and ancillary supplies -including import/export logistics and supply destruction processes- are in place as applicable.
Manage operational aspects to support subject recruitment and retention, patient safety, vendor performance, and the monitoring visit strategy.
Proactive planning for monitoring activities to ensure data integrity, patient safety and endpoint protection.
Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management.
Oversight and approval of site payments, including payment reconciliation.
Foster effective communication and collaboration with clients and cross-functional project teams in a global and multicultural environment.
Ability to lead client-facing calls to communicate project status updates and demonstrate operational control of start-up and clinical deliverables.
Support new business with active participation in pre-award preparation as required.
Provides training and support to new and/or junior team members All other duties as needed or assigned.
Qualifications (Minimum Required):
University/college degree (life science preferred) or certification in a related allied health profession (nursing, medical, or laboratory technology) from an appropriately accredited institution.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Fluent in English, both written and verbal
Experience (Minimum Required):
Five or more years of relevant clinical research experience in pharmaceutical, CRO, or health care setting will be considered.
Comprehensive knowledge of GCP, ICH, and regulatory guidelines.
Proficiency in Microsoft Office and familiarity with EDC, CTMS, eTMF, and vendor platforms (e.g. Veeva Vault, Medidata).
Effective leadership in remote and global environment.
Strong communication, planning, and organizational abilities.
Proven team motivational skills.
Proficiency in balancing concurrent tasks within time-sensitive environments.
Financial awareness and use of tracking systems/tools.
Demonstrated independent problem-solving and risk management mindset.
Demonstrated professional client interaction and presentation skills, with ability to work independently and collaboratively.
In this role, employees will leverage their existing experience and skills to assume additional responsibilities within the broader role. These will be aligned with operational requirements and internal training, without altering the fundamental nature or classification of the position.
Preferred Qualifications Include:
Master’s or other advanced degree.
PMP certification or equivalent.
Physical Demands / Work Environment:
Remote-based work required with possible office presence depending on location.
Travel requirements: up to 20% (global – primarily domestic and international)
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