Clinical Data Management Associate

hace 2 semanas

San José, Costa Rica MicroPort Orthopedics SA A tiempo completo

At MicroPort, we relentlessly strive to master every detail of our medical solutions to prolong and reshape patients' lives everywhere. We welcome motivated and talented people who want to join our dynamic and inclusive company, working together to deliver meaningful medical breakthroughs. To accomplish this, we hold to our core values of Quality, Integrity, Accountability, Efficiency, Innovation, Aspiration, Dedication & Collaboration. Come and join Team MicroPort

**Why You'll Love MicroPort**

You will find our team atmosphere warm, challenging, and rewarding. In addition to working with a world-class team locally and abroad and receiving a competitive salary, our Costa Rican employees also enjoy the following benefits: Medical Insurance which includes Dental and Vision, Leaves of Absence including Bereavement, Maternity and Paternity Leave, Studies, paid and nonpaid additional days; Seniority Days, Paid Holidays (10 each year), Education Assistance...and more At Microsoft, we care about our employees.

**Your duties will include**:

- Acting as the primary or supporting data manager responsible for study-specific study start-up tasks, including case report form (CRF) design, edit check creation, CRF completion guideline (CCG) creation, and user acceptance testing, including leading process improvements and enhancements, as needed.
- Participating in and leading data validation tasks for various studies during maintenance and close-out, focusing on data integrity and quality metrics.
- Participating in and leading the data management plan (DMP) development and maintenance.
- Participating in or leading ongoing operational support for all activities and at times leading specific projects or tasks, during clinical trial conduct, including database migrations, ad-hoc report creation, maintenance of external data transfer documents, import/export agreements and data specifications, and support for database lock and archiving activities.
- Ensuring that user administration in data management-owned systems and Trial Master File document filing is accurate and timely.
- Manage the planning, implementation, and overall direction of executing clinical trial data management activities including protocol review, electronic system configuration, Case Report Form (CRF/eCRF) design, database development, validation programming, and discrepancy management.
- Manage/oversee EDC database builds including CRF design, edit check specifications, and validation of the clinical database.
- Perform User Acceptance Testing (UAT) including validating data entry screens and testing edit checks. Report errors to the database programmer and assist them in making appropriate corrections.
- Generate data management documents appropriate for the clinical trial, including but not limited to the Case Report Form (CRF), Data Management Plan (DMP), CRF Completion Guidelines (CCG), and Data Validation Specification (DVS).
- Design reports and metrics that are useful management tools for your projects;
- Creates and oversees EDC build and database lock timelines in order to maintain on-time deliverables;
- Coordinate overall data management by serving as primary contact for the sponsor, external data providers, and all project team members
- Ensure compliance with EMEA, FDA, ICH GCP regulations and policies, and appropriate Sponsor SOP in regards to data management
- Responsible for all data management activities, sponsor relationship management, development and implementation of data correction processes, resolution, data control, and validation.
- Prepare, review, and submit appropriate data management documents for upload to the Trial Master File.

**Other Duties** Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

**About You**

**We might be a great match if you**:

- Have computer experience with databases, and spreadsheet.
- Possess an understanding of database structure and processes in data management; and
- Have a basic knowledge of medical terminology is needed, as well as knowledge of clinical research methodologies.
- Have any knowledge of EDC solutions (Oracle Clinical, Medidata RAVE, Inform, etc.).
- Have a current computer literacy in appropriate software (i.e., Current with recent versions of Microsoft Office software suite).
- Posses excellent interpersonal, written, and oral communication skills.
- Are fluent in English - written and verbal (B2+ or above).
- Are accurate and have attention to detail as it is essential.
- Have a thorough and proven understanding of the principles of data management and administration.
- Have proven ability to advise on data management strategies development, is detail-oriented focus and has strong analytical thinking skills.
- Have proven ability to communicate concise

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