Clinical Data Coordinator (Philippines)

Indero; Philippines; Remote; PHP 600,000 - 900,000; Full time

Benefits offered by this job

Flexible work schedule

Permanent full-time position

Ongoing learning and development

Job summary

Indero is seeking a Clinical Data Coordinator to support data management activities for clinical trials conducted or managed by Indero. This role emphasizes data accuracy, regulatory compliance, and collaboration with sponsors and vendors.

You will work in a fast-paced, home-based position in the Philippines, with responsibilities spanning data review, discrepancy management, and study reporting, while ensuring documentation stays current in the TMF.

Qualifications

• B.Sc. or related field.
• 1 year CDM experience in pharma or CRO is a plus.
• Experience with EDC systems (Medidata Rave, Medrio) is an asset.
• Strong English; French is a plus.
• Well organized with good time management.

Responsibilities

• Provides general data management support to the project team, sponsor and external vendors.
• Supports Lead Data Manager in Data Review, Data Reconciliation, Discrepancy Management.
• Maintains study metrics and monitors study status; provides data status reports.
• Generates Ad-Hoc Study Reports and assists with designing of database.
• Assists in creating the data management plan and TMF documentation.

Skills

Analytical skills

Data management

English proficiency

Team collaboration

Education

B.Sc. or related field

Tools

Medidata Rave

Medrio

Job description

The Clinical Data Coordinator will participate in various clinical data management activities required to ensure that data captured in clinical trials undertaken, or managed by Indero, are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines.This role will be perfect for you if:You have strong analytical capacities and an ease to work with data.You enjoy working with systems and technology, continuously learning.You want to work in a collaborative team where your ideas are heard and valued.RESPONSIBILITIES-Provides general data management support to the project team, sponsor and external vendors, as needed.-Supports Lead Data Manager in the areas of:Data Review.Data Reconciliation.Discrepancy Management.Maintenance of Study Metrics; Monitoring study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provide data status reports to the project team, as needed.Generation of Ad-Hoc Study Reports.User Maintenance.Assisting with User Acceptance Testing.Assisting with designing of database.Assisting with creating data management plan (DMP), and other clinical data management related documentation.Assisting in ensuring that data management documentation is complete and up-to-date in the trial master file (TMF).Requirements:IDEAL PROFILEEducationB.Sc. or related field;Experience1 year of clinical data management experience in the pharmaceutical industry or in a CRO environment is considered an asset;Experience using an EDC system (ie. Medidata Rave, Medrio) is considered an important asset.Knowledge and skillsSkilled in use of computer technology, and ability to learn new applications;A general knowledge of CDASH/SDTM is considered an assetHighly organized and detail-oriented with effective project planning and time management skills;Strong verbal and written communication skills in English, French is an asset;Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands;Excellent interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment.Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.Brand name:InderoOur company:The work environmentAt Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.In this position, you will be eligible for the following perks:Flexible work schedulePermanent full-time positionOngoing learning and developmentWork locationNote that this opening is for a home-based position in Philippines. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.About InderoA Global Clinical Leader In Dermatology and Rheumatology!Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.Indero only accepts applicants who can legally work in Philippines.