Clinical Data Manager (CRO -Healthcare)

The biggest opportunity in the first research organization by Thai startups. 🌈 Clinixir looking for outstanding candidates to be a part in building and driving CRO to grow globally.The Clinical Data Manager (CDM) oversees the collection, processing, and management of clinical trial data. This role ensures data accuracy, quality, and compliance with regulatory standards. Responsibilities include designing and implementing data management plans, developing and validating databases, performing data reviews, resolving discrepancies, and coordinating with cross-functional teams to meet project goals and timelines.Key Deliverables:Data Management Plans (DMP)Case Report Form (CRF)Clinical DatabasesOther documents related to data management, such as Data Entry Guidelines, Data Validation Specification, Edit Checks Specification, etc.Study Data ReportsCollaborating with study team, clients or others regarding data management in assigned studiesResponsibilities:Oversee the entire clinical data management process for multiple studies.Develop, review, and implement data management plans for clinical trials.Design Case Report Forms (CRFs) or Electronic Case Report Forms (eCRFs) with the study team according to clinical protocol and data requirements, ensuring high data quality and accuracy to meet analysis needs.Design and implement clinical trial databases or Electronic Data Capture (EDC) systems, maintain EDC, and manage system user access.Oversee the study database for data collection and develop data management related documents, e.g., Data Entry Guidelines, Data Validation Specification, Edit Checks Specification, etc. in accordance with standard practice guidelines and study timeline.Ensure data quality by reviewing, cleansing, and reconciling data, resolving discrepancies, performing quality checks, managing queries, and ensuring timely delivery. Collect, process, and report high-quality data, and develop, validate, and prepare databases for transfer and analysis following procedures.Perform database lock procedures and archiving the study data and documents when the trial is closed.Provide the standard study data management status reports to the study team and clients. Being proactive and providing timely communication of project status, reports, data trends and resolution to issues to the study team and clients.Ensuring proper planning and execution for data management deliverables that meet standards and timelines.Define processes for handling change control issues, including when revalidation is necessary due to data management changes. Serving as the primary contact for assigned projects to interact with clinical counterparts for overall project planning and issue resolution.Develop, review and maintain Data Management SOPs according to the organization’s documented quality system.Develop and maintain training materials for data management activities.Provide technical expertise and guidance related to data management processes to other functional areas.Collaborate with senior management and cross-functional teams, including clients and sites, to align data management activities with overall project goalsParticipate in the assigned project meeting, prepare presentation and materials for the meeting.Ensure that data management activities are conducted in compliance with Good Clinical Practices (GCP), study-specific guidelines, other regulatory requirements, and industry standards (such as 21 CFR Part 11, HIPPA).Coordinate with external vendors and service providers involved in clinical trial data management activities, such as Clinical Trial Management System (CTMS) or EDC.Supervises and trains Clinical Data Associate. Participate in audits and inspections of data management activities as required.Other tasks as delegated.QualificationsBachelor’s degree or equivalent formal academic qualification in Data Management, Biostatistics, Statistics, Computer Science, or a related field.Minimum of 3 years of experience in clinical data management or related fields (CRO - HealthCare) Experience in clinical data management systems and software.Strong understanding of data management principles and practices.Effective communication and interpersonal skills in Thai and English.Knowledge of regulatory requirements and guidelines (such as GCP, GCDMP, FDA, EMA, 21 CFR Part 11).Good understanding of medical terminology and medications Excellent skills using Microsoft Office Suite: MS Excel, MS Word, and MS PowerPoint.Results driven with meticulous attention to detail, ability to effectively manage multiple tasks and projects, organizing, and problem-solving skills.Good self-management abilities, able to adapt to changing and competing priorities, ability to work creatively and flexibly, both independently and as part of a team.Desire and ability to learn new skills, systems, and processes.Experience in the pharmaceutical or biotechnology industry or related fields is desirable.Knowledge of relational database concepts, programming, and SQL language or related programming language (such as Java Script) is desirable.Knowledge of CDISC/ CDASH data standards is desirable.Certification in clinical data management (e.g., CCDM) is desirable.Good Benefit- Annual Leave 15 Days- Birthday leave 1 Day- Medical Insurance-Provident Fund-Annual health check with flu vaccination** Flexible Working Hour**Clinixir Office, 173/18 Asia Centre Building (BTS Chongnonsi)