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Key Responsibilities and Required Skills for Clinical Trials Analyst

💰 $70,000 - $110,000

Clinical ResearchBiotechHealthcareRegulatory AffairsData Management

🎯 Role Definition

The Clinical Trials Analyst is a subject-matter expert responsible for supporting the design, execution, monitoring, and close-out of clinical studies across the clinical trial lifecycle. This role ensures protocol compliance, high-quality clinical data capture (EDC/eCRF), robust safety and regulatory reporting (ICH‑GCP/FDA), and collaborative project delivery with cross-functional teams including clinical operations, data management, biostatistics, regulatory affairs, pharmacovigilance, and study sites.

Key responsibilities include clinical monitoring support, data review and query management, CTMS administration, safety case triage and expedited reporting, preparation of regulatory documentation, trend analysis, and continuous process improvement to drive study timelines and quality outcomes.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Coordinator (CRC) supporting investigator sites and study visits
  • Research Assistant with experience in source documentation and study filing
  • Data Coordinator or Junior Data Manager familiar with EDC systems and query resolution

Advancement To:

  • Senior Clinical Trials Analyst (lead responsibilities over multiple studies)
  • Clinical Project Manager / Clinical Operations Manager (oversight of study delivery)
  • Clinical Program Manager or Head of Clinical Operations

Lateral Moves:

  • Clinical Research Associate (CRA) — field monitoring and site oversight
  • Regulatory Affairs Specialist — IND/CTA submissions and regulatory strategy
  • Pharmacovigilance / Safety Specialist — dedicated safety operations and case management

Core Responsibilities

Primary Functions

  • Lead operational review and reconciliation of clinical trial data in EDC (electronic data capture) systems and ensure eCRF completeness, accuracy, and timely query closure to support database lock readiness.
  • Conduct protocol compliance reviews and site performance assessments, identify deviations and CAPA (corrective and preventive actions), and prepare detailed monitoring reports for study teams and sponsors.
  • Manage and maintain CTMS (Clinical Trial Management System) records, including milestones, site activation status, enrollment tracking, and regulatory document inventories to support accurate project reporting.
  • Triage, document, and escalate safety signals and adverse event reports to pharmacovigilance and regulatory teams, ensuring timely expedited reporting (SUSARs, SAEs) in accordance with ICH‑GCP and local regulatory requirements.
  • Prepare, review, and assemble regulatory submission packages (e.g., IND, CTA, protocol amendments) and update regulatory trackers to support submissions to IRBs/ECs and health authorities.
  • Support study startup activities including site feasibility assessments, site initiation visit coordination, training on protocol and EDC workflows, and verification of essential regulatory documentation.
  • Perform source data verification (SDV) planning and execution in collaboration with CRAs and site staff, ensuring source-to-CRF concordance and data integrity across critical endpoints and safety data.
  • Generate and deliver routine and ad hoc study metrics, dashboards, and trend analyses (enrollment, query rates, data quality indicators) to clinical operations leadership and cross-functional stakeholders.
  • Design and execute data cleaning strategies, manage open queries, and coordinate resolution between sites, data management, and clinical teams to reduce rework prior to database lock.
  • Support medical coding activities (e.g., MedDRA, WHO‑Drug) and collaborate with clinical coding partners to ensure consistent adverse event and concomitant medication classification.
  • Perform line-level review of clinical study documents for completeness and compliance with SOPs, templates, and GCP standards, and prepare documentation for internal and external audits.
  • Coordinate interim and final clinical study report (CSR) drafting activities by compiling datasets, tables, listings, and figures in collaboration with biostatistics and medical writing teams.
  • Execute risk-based monitoring (RBM) activities and centralized monitoring reviews, flagging sites for targeted monitoring and recommending optimization of monitoring plans.
  • Assist with protocol and CRF design reviews to identify ambiguities, reduce data entry burdens, and ensure capture of critical safety and efficacy endpoints for robust statistical analysis.
  • Maintain training records and competency documentation for site staff and cross-functional colleagues on protocol requirements, safety reporting procedures, and EDC usage.
  • Provide hands-on support for vendor oversight, including laboratory, central imaging, and specialized service providers, ensuring SLAs, deliverables, and data transfers meet study requirements.
  • Support change control and configuration management of clinical systems used in study conduct; validate updates and communicate changes to study teams and sites.
  • Participate in site selection and feasibility analysis by reviewing investigator experience, past performance metrics, and site infrastructure to improve enrollment probability and data quality.
  • Coordinate and participate in investigator meetings, sponsor/study team calls, and cross-functional study working groups to align timelines, resolve operational challenges, and document action items.
  • Perform end-to-end reconciliation of investigational product (IP) accountability records with site logs and pharmacy records and escalate discrepancies per protocol and investigational plan.
  • Support quality assurance activities including mock inspections, gap analyses, root cause investigations, and implementation of corrective actions resulting from audits or vendor findings.
  • Prepare and maintain clear, audit-ready trial documentation (TMF/ISF) ensuring indexation, completeness, and timely filing according to eTMF guidelines and regulatory expectations.
  • Collaborate with biostatistics and data managers to support interim analyses, DSMB submissions, and data cut procedures, ensuring controlled access, reproducibility, and traceability.
  • Continuously review industry best practices and contribute to SOP updates, template improvements, and process automation opportunities to increase operational efficiency and compliance.

Secondary Functions

  • Support cross-functional initiatives such as patient recruitment campaigns, retention strategy development, and decentralized trial implementation pilots.
  • Lead or contribute to post-marketing and real-world evidence (RWE) data collection efforts when studies transition to registries or pragmatic trials.
  • Assist with vendor selection, contract review, and KPI monitoring for third-party providers supporting imaging, central labs, CRO activities, and ePRO vendors.
  • Provide mentoring and training to junior analysts, CRAs, and site staff on monitoring practices, data quality expectations, and regulatory requirements.
  • Contribute to continuous improvement projects and data-driven process optimization, including automation of routine tasks, standardization of monitoring templates, and improvement of query workflows.
  • Participate in product development meetings to provide operational input on study feasibility, timelines, and resource needs from a clinical operations perspective.
  • Support regulatory inspections and health authority interactions by preparing responses, compiling requested documents, and coordinating internal SME reviews.
  • Assist with budget tracking and resource forecasting for study activities, including site budgeting, monitoring projections, and vendor spend tracking.

Required Skills & Competencies

Hard Skills (Technical)

  • Proven expertise in ICH‑GCP guidelines, FDA/EMA regulations, and regional regulatory requirements for clinical research.
  • Experience with EDC systems (e.g., Medidata Rave, Oracle InForm, REDCap) for eCRF review, query management, and data cleaning.
  • Proficiency in CTMS platforms (e.g., Veeva, Clintracker, Oracle CTMS) for site tracking, milestone management, and enrollment reporting.
  • Practical knowledge of clinical data standards and coding (MedDRA, WHO‑Drug) and familiarity with SDTM/ADaM concepts is a plus.
  • Hands-on experience with safety reporting workflows and case management systems, including expedited SAE/SUSAR submission processes.
  • Strong analytical skills and experience using Excel (pivot tables, VLOOKUP), Tableau/Power BI, or similar visualization tools to create monitoring dashboards and KPI reports.
  • Understanding of study startup processes, regulatory submission documentation, IRB/EC interactions, and site activation requirements.
  • Experience with risk-based and centralized monitoring methodologies, including statistical monitoring techniques and trigger-based escalations.
  • Familiarity with clinical trial document management systems and eTMF best practices to maintain inspection-ready documentation.
  • Basic statistical literacy and experience working with biostatistics teams on interim analyses, data cuts, and CSR deliverables.
  • Experience working with CROs, vendors, and external partners with ability to oversee deliverables, timelines, and quality metrics.
  • Knowledge of electronic trial systems change control, validation principles, and GxP computerized system compliance.

Soft Skills

  • Strong written and verbal communication skills for clear monitoring reports, regulatory documents, and stakeholder updates.
  • Exceptional attention to detail with demonstrated ability to identify data anomalies and protocol non-compliance.
  • Project management capability: prioritize tasks, manage competing deadlines, and coordinate cross-functional teams.
  • Critical thinking and problem-solving mindset with a continuous improvement orientation.
  • Interpersonal skills and diplomacy to work effectively with investigators, site staff, internal colleagues, and CRO partners.
  • Adaptability and resilience in a fast-paced environment with shifting regulatory and operational priorities.
  • Ability to train and mentor junior staff and promote knowledge-sharing across clinical teams.
  • High ethical standards and commitment to patient safety, data integrity, and compliance.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in a life sciences, nursing, pharmacy, public health, or related scientific discipline.

Preferred Education:

  • Master's degree (MS, MPH) in Clinical Research, Public Health, or Life Sciences, or professional degree (RN, PharmD) is advantageous.
  • Certifications such as ACRP, SOCRA, or GCP certification are highly desirable.

Relevant Fields of Study:

  • Clinical Research / Clinical Science
  • Nursing / Pharmacy / Medicine
  • Pharmacology / Toxicology
  • Public Health / Epidemiology
  • Biostatistics / Data Science (for data‑intensive roles)

Experience Requirements

Typical Experience Range:

  • 2–5 years clinical research experience (site or sponsor side); candidates with 1–2 years plus strong EDC/CTMS experience may be considered for junior roles.

Preferred:

  • 3–5+ years of experience supporting phase I–IV clinical trials, including hands-on exposure to monitoring, safety reporting, regulatory submissions, and cross‑functional study support.
  • Experience in therapeutic areas such as oncology, immunology, rare diseases, CNS, or cardiology is a plus.
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