Key Responsibilities and Required Skills for Clinical Trials Officer

🎯 Role Definition

The Clinical Trials Officer (CTO) is a central operational role in clinical research responsible for planning, coordinating, and overseeing the day-to-day delivery of interventional and observational clinical studies. The CTO ensures trials are conducted in compliance with ICH-GCP, local regulations, sponsor and institutional requirements, and study protocols. This role manages study start-up activities, site relationships, regulatory submissions, safety reporting, data quality oversight, and Trial Master File (TMF) maintenance. The ideal Clinical Trials Officer balances strong regulatory and operational knowledge with excellent stakeholder communication and project management skills to drive timely, high-quality clinical trial delivery.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator (CRC) at investigative sites
Clinical Trial Assistant (CTA) / Study Coordinator in sponsor or CRO settings
Research Nurse or Clinical Data Coordinator moving into trials operations

Advancement To:

Senior Clinical Trials Officer / Study Manager
Clinical Project Manager / Clinical Operations Manager
Senior Clinical Research Associate (CRA) or Head of Clinical Operations
Regulatory Affairs Manager (for those focusing on submissions)

Lateral Moves:

Clinical Quality Assurance or GCP Compliance roles
Clinical Data Management or Biostatistics liaison positions
Vendor management or clinical supply chain roles

Core Responsibilities

Primary Functions

Lead and coordinate site selection, feasibility assessments, and study start-up activities including preparation of study initiation packages, site initiation visits, and activation tracking to ensure sites are ready to enroll to protocol timelines.
Manage regulatory submissions and ongoing compliance: prepare and submit IRB/EC packages, Clinical Trial Applications (CTA/IND/IDE where applicable), protocol amendments, and regulatory reports; monitor approval timelines and maintain submission logs.
Oversee Trial Master File (TMF) creation and maintenance to ensure completeness, accuracy, version control, and audit readiness in accordance with ICH-GCP and sponsor/CRO standards.
Act as the primary operational contact between sponsor/CRO and investigative sites, coordinating communications, escalating issues, and ensuring clear expectations and timely resolution of operational queries.
Monitor study progress against enrollment targets, timelines and milestones; generate and deliver weekly/monthly study status reports, enrollment dashboards, and corrective action plans when variances are detected.
Support, coordinate or conduct on-site and remote monitoring activities including source data verification, informed consent verification, protocol adherence checks, and identification of data discrepancies for resolution with site staff.
Coordinate and manage serious adverse event (SAE) reporting and expedited safety notifications: ensure timely collection, validation, coding (MedDRA), and transmission of safety reports to sponsors, IRBs, and regulatory authorities as required.
Manage Investigator Site File (ISF) and essential regulatory documents at the site level, ensuring all documents are current, signed, and archived per retention policies and inspection readiness standards.
Facilitate and document informed consent process oversight: review consent forms, confirm proper consent procedures, resolve consent-related queries, and track consent form versions and re-consent requirements.
Lead vendor and subcontractor management for study-specific vendors (central labs, imaging vendors, eCOA, IVRS/IWRS, local CROs), including scope reviews, SLA monitoring, deliverable tracking, and performance escalations.
Support site budget development, tracking and financial reconciliation: prepare budget templates, liaise with finance and contracting teams, process payments and monitor enrollment-based payments to investigative sites.
Coordinate protocol amendment implementations across sites: update study documents, support re-training of site staff, manage regulatory resubmissions and confirm all sites transition to revised protocol versions.
Ensure data quality by working closely with Data Management and Biostatistics teams to facilitate query resolution, source data reconciliation, and discrepancy management in EDC systems (e.g., Medidata Rave, Oracle, Veeva).
Prepare and manage site training materials and Investigator Meetings: develop training slides, job aids, and SOP refreshes; deliver or coordinate training sessions on protocol procedures, safety reporting and eCRF completion.
Conduct quality checks, internal audits and monitor corrective and preventive actions (CAPAs) to resolve protocol deviations, documentation gaps and non-compliance, preparing responses for regulatory inspections when required.
Compile, author and review study documentation for regulatory submissions, clinical study reports, periodic safety update reports and site communications, ensuring accuracy, traceability and sponsor alignment.
Manage specimen, shipping and sample handling logistics in collaboration with central labs and sites to ensure chain-of-custody, temperature control, labeling accuracy and compliance with sample retention policies.
Maintain and update study risk assessments and risk-based monitoring plans, using metrics-driven approaches to allocate monitoring resources and reduce high-risk activities.
Support contract negotiations and clinical trial agreements with investigative sites and vendor partners, ensuring clauses align with regulatory requirements, indemnity, IP, payment milestones and data sharing terms.
Coordinate close-out activities including site close-out visits, final TMF reconciliation, archival planning, and final study reporting to sponsors and regulatory bodies.
Actively contribute to development and maintenance of SOPs, work instructions and process improvements to increase efficiency, reduce errors and ensure consistent clinical operations practices across studies and regions.
Provide operational input into trial design and feasibility assessments with study teams during protocol development to ensure practical site procedures, recruitment assumptions and data collection strategies.
Serve as a primary resource during audits and inspections: prepare documentation, support site and sponsor responses, implement corrective actions and ensure closure of audit findings.

Secondary Functions

Support cross-functional study teams (clinical science, pharmacovigilance, data management, regulatory affairs) with operational input and practical feasibility assessments.
Maintain study trackers, metrics dashboards, and KPI reporting to demonstrate operational performance, enrollment trends, and quality indicators to stakeholders.
Mentor and train junior CTAs/CRAs on operational processes, TMF standards, and site engagement best practices.
Participate in process improvement initiatives and digital transformation projects (CTMS rollouts, eTMF migrations) to improve operational efficiency and compliance.
Contribute to vendor selection exercises by developing criteria, participating in vendor assessments and feeding into commercial evaluations.

Required Skills & Competencies

Hard Skills (Technical)

In-depth knowledge of ICH-GCP guidelines, local regulation for clinical trials, and experience preparing IRB/EC and regulatory submissions.
Trial Master File (TMF) management skills with experience using eTMF systems (e.g., Veeva Vault, TransPerfect, Docusign migrations).
Hands-on experience with EDC/CTMS platforms such as Medidata Rave, Oracle Clinical, Veeva, Castor or similar, including query management workflows.
Clinical monitoring and site management experience: conducting site initiation, monitoring and close-out visits, remote monitoring, and source data verification.
Adverse event and safety reporting expertise including SAE collection, MedDRA coding basics, and working knowledge of pharmacovigilance timelines.
Strong document control, regulatory documentation writing and versioning skills for protocols, informed consent forms, and regulatory correspondence.
Project management skills with experience creating and managing timelines, Gantt charts, risk registers, and milestone reporting in a matrix environment.
Vendor and contract management experience including drafting SOWs, monitoring SLAs, and coordinating deliverables from central labs, imaging or third-party vendors.
Experience with quality assurance processes: internal audits, CAPA tracking, inspection readiness and corrective action implementation.
Practical knowledge of clinical trial budgeting and payments, site invoice review, and financial tracking within sponsor/CRO frameworks.
Familiarity with specimen logistics and handling requirements, chain-of-custody, and cold-chain shipping processes.
Proficiency in Microsoft Office suite (Excel pivot tables, PowerPoint presentations) and data visualization tools for operational reporting.

Soft Skills

Excellent written and verbal communication skills for clear, persuasive reporting to sponsors, investigators, and cross-functional teams.
Strong stakeholder management and collaboration skills to align internal teams, investigators, CROs and vendors around study objectives.
Analytical and problem-solving mindset with attention to detail to spot trends, data anomalies and compliance risks early.
Time management and prioritization skills in a fast-paced clinical operations environment handling multiple studies or sites.
Adaptability and resilience when managing protocol changes, regulatory delays, or site performance challenges.
Leadership and mentoring ability to coach junior staff and influence cross-functional peers without direct authority.
High ethical standards and integrity when handling patient data, safety information, and regulatory documentation.
Customer-focused approach with an emphasis on site relationship building and investigator engagement to optimize recruitment and retention.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in life sciences, nursing, pharmacy, public health, biomedical sciences, or related discipline.

Preferred Education:

Master’s degree in Clinical Research, Public Health, Life Sciences, or MBA with clinical research experience; or equivalent professional training plus relevant certifications.

Relevant Fields of Study:

Clinical Research / Clinical Trial Management
Nursing, Pharmacy or Biomedical Sciences
Public Health / Epidemiology
Regulatory Affairs / Health Sciences

Experience Requirements

Typical Experience Range:

2 to 5 years of direct experience in clinical trials operations, site management or related clinical research roles for a mid-level CTO; 0–2 years for entry-level CTA moving into CTO; 5+ years for senior-level positions.

Preferred:

3+ years of hands-on experience in sponsor or CRO study management or as a CRA/CRC with demonstrated responsibility for site oversight, regulatory submissions, TMF maintenance and safety reporting.
Prior experience with multi-center, multi-country trials and familiarity with regional regulatory environments for the jurisdictions supported.

Certifications that add value: ICH-GCP certification, ACRP or SOCRA certification, PMI/PRINCE2 or Clinical Project Management certificates, or specialized eTMF/CTMS platform training.