Senior Clinical Documentation Specialist

🏗 We're Hiring: Senior Clinical Documentation Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Experience Level: Mid-Level to Senior

Work Arrangement: Fully Remote

About Us

We are a construction-focused organization committed to delivering complex projects through disciplined contract management, commercial excellence, risk control, and collaborative project delivery. Our distributed teams collaborate across Project Management, Construction, Engineering, Procurement, Commercial, Legal, Finance, Human Resources, Design, Quality, HSE, Consultants, Contractors, Suppliers, Logistics, Administration, Information Technology, and Executive Leadership to maintain high standards of documentation accuracy, regulatory compliance, information governance, quality assurance, and professional accountability across diverse industries and business functions.

We value precision, transparency, continuous improvement, and responsible information management. Through structured documentation processes, effective quality controls, and cross-functional collaboration, we aim to ensure that our records, project deliverables, and regulated documentation meet applicable legal requirements and recognized industry standards.

The Role

We are seeking an experienced Senior Clinical Documentation Specialist to oversee the preparation, review, organization, maintenance, and quality control of clinical documentation across relevant clinical research, healthcare, pharmaceutical, and life sciences activities. The ideal candidate will bring strong expertise in clinical document management, Good Clinical Practice (GCP), controlled documentation, clinical study records, quality assurance, regulatory documentation, and audit readiness.

This role will focus on ensuring clinical documents are accurate, complete, consistent, traceable, and maintained throughout their lifecycle. The Senior Clinical Documentation Specialist will collaborate with Clinical Operations, Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, Data Management, Legal, external research partners, and senior leadership to ensure that applicable documentation practices comply with relevant United Arab Emirates laws and regulations, applicable international standards, contractual obligations, and organizational procedures.

Key Responsibilities

• Develop, implement, maintain, and improve clinical documentation policies, procedures, work instructions, and document control practices.
• Establish standardized processes for the preparation, review, approval, distribution, retention, and archival of clinical documents.
• Ensure that clinical documentation meets applicable regulatory requirements, study protocols, quality standards, and organizational procedures.
• Maintain compliance with relevant Good Clinical Practice (GCP) requirements and other applicable clinical research standards.
• Coordinate clinical document lifecycle management from initial drafting through approval, controlled use, revision, and archival.
• Prepare, review, edit, and format clinical documentation to ensure clarity, accuracy, consistency, and completeness.
• Maintain clinical study documentation, including protocols, investigator brochures, informed consent forms, clinical study reports, and study-related correspondence, where applicable.
• Support the preparation and maintenance of essential clinical trial documents in accordance with applicable requirements.
• Ensure that required clinical records are appropriately filed, indexed, version-controlled, and readily retrievable.
• Maintain Trial Master File (TMF) and Investigator Site File (ISF) documentation processes in accordance with established procedures, where applicable.
• Monitor the completeness, accuracy, and timeliness of essential document filing across clinical studies.
• Conduct periodic documentation reviews to identify missing records, outdated versions, filing errors, and inconsistencies.
• Coordinate with clinical study teams to obtain missing documents and resolve documentation deficiencies.
• Maintain document trackers, filing plans, completeness reports, and outstanding action logs.
• Ensure that document naming conventions, metadata, indexing structures, and classification standards are consistently applied.
• Review documents for appropriate authorship, approval status, effective dates, revision history, and supporting references.
• Verify that documents are reviewed and approved by authorized personnel before implementation or distribution.
• Maintain controlled templates, forms, checklists, and standard document formats for clinical activities.
• Coordinate document review workflows among Clinical Operations, Medical Affairs, Regulatory Affairs, Quality Assurance, and other relevant stakeholders.
• Monitor review timelines and follow up on overdue approvals, comments, and required revisions.
• Consolidate reviewer feedback and ensure that comments are resolved and documented appropriately.
• Maintain clear audit trails for document creation, modification, review, approval, and distribution.
• Support the management of clinical documentation within electronic document management systems (EDMS) and electronic Trial Master File (eTMF) platforms.
• Ensure that electronic systems support appropriate access controls, version management, traceability, retention, and retrieval.
• Assist with user acceptance testing, system validation documentation, and controlled implementation of clinical documentation systems where applicable.
• Collaborate with IT and system administrators to resolve document management issues and improve system usability.
• Ensure that electronic records and signatures are managed in accordance with applicable regulatory and organizational requirements.
• Maintain appropriate safeguards for confidential clinical information, personal data, and sensitive research documentation.
• Support document redaction, anonymization, and controlled disclosure activities where required.
• Ensure that clinical documentation is handled in accordance with applicable privacy, confidentiality, and data protection requirements.
• Assist in preparing clinical documents for regulatory submissions, ethics committee reviews, and other formal approval processes.
• Coordinate the compilation of supporting documents required for clinical trial applications, amendments, and regulatory responses where applicable.
• Review documentation packages for completeness, consistency, and alignment with submission requirements.
• Maintain submission records, correspondence, approval letters, and related documentation in controlled repositories.
• Track clinical document requirements associated with protocol amendments, study changes, investigator updates, and regulatory commitments.
• Ensure that revised documents are distributed appropriately and superseded versions are withdrawn from active use.
• Support the preparation, review, and maintenance of clinical study protocols and amendments.
• Coordinate updates to informed consent forms, participant information sheets, investigator documentation, and study-related materials.
• Ensure that clinical documents are consistent with approved protocols, applicable ethics requirements, and current study information.
• Support the preparation and quality review of clinical study reports, clinical summaries, and supporting scientific documentation.
• Verify consistency across study reports, data listings, tables, figures, and referenced source materials.
• Assist with the preparation and maintenance of clinical sections of regulatory dossiers and submission packages.
• Support document preparation for medical writing activities, including scientific summaries, study narratives, and clinical evidence reports.
• Coordinate with medical writers, statisticians, clinical researchers, and data management personnel to resolve documentation discrepancies.
• Ensure that clinical documentation accurately reflects approved study procedures, results, and documented decisions.
• Support the preparation and maintenance of clinical safety documentation in coordination with Pharmacovigilance teams.
• Ensure that relevant safety records, case-related documentation, and safety correspondence are appropriately filed and traceable.
• Coordinate documentation exchanges between internal teams, contract research organizations (CROs), clinical sites, laboratories, and external service providers.
• Monitor document delivery requirements under study plans, quality agreements, and contractual obligations.
• Support the preparation and maintenance of clinical vendor documentation, qualification records, and oversight evidence.
• Maintain records of investigator qualifications, training documentation, delegation logs, and other essential site records where applicable.
• Ensure that clinical training records and documented acknowledgments are complete and current.
• Support the preparation of clinical documentation for internal audits, sponsor audits, regulatory inspections, and quality assessments.
• Conduct periodic document readiness reviews to verify the availability and completeness of essential records.
• Coordinate the collection and presentation of document evidence requested during audits and inspections.
• Track audit observations, documentation deficiencies, and remediation actions through to resolution.
• Support root cause analysis and corrective and preventive action (CAPA) activities related to documentation issues.
• Monitor CAPA implementation and verify that corrective actions address the underlying causes of identified deficiencies.
• Identify recurring document errors, filing delays, version control problems, and process inefficiencies.
• Develop and monitor key performance indicators for document quality, filing completeness, review turnaround, approval timelines, and outstanding actions.
• Prepare periodic documentation status reports, quality summaries, completeness metrics, and management updates.