Senior Clinical Data Manager / Principal Clinical Data Manager

Precision Medicine Group; España; A distancia; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading clinical research organization is seeking a Senior Clinical Data Manager to oversee all aspects of clinical trial data management. Responsibilities include managing project data entry, ensuring data quality, and training personnel. Candidates can work remotely from several countries including Spain. This role requires a Bachelor's degree and experience in clinical research. Proficiency in English and Microsoft Office is also essential.

Formación

• Bachelor's degree and/or a combination of related experience.
• Experience as a Lead Data Manager for a Clinical Research Organisation.
• Professional use of the English language; both written and oral.

Responsabilidades

• Oversee data management for assigned clinical projects.
• Develop CRF specifications and coordinate stakeholder feedback.
• Perform quality control of data entry and review clinical trial data.

Conocimientos

Leadership

Organizational skills

Communication skills

Data Management

Clinical Research

Proficiency in Microsoft Office

Educación

Bachelor's degree or equivalent experience

Herramientas

Clinical database management systems

Descripción del empleo

Position Summary

The Senior Clinical Data Manager / Principal Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start‑up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs / WIs), regulatory directives, and study‑specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. It is a remote position; candidates can be based in Serbia, Spain, UK, Hungary, Poland, Romania or Slovakia.

Essential Functions

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring back‑up, continuity, responsiveness, and timely task completion. May support another Lead DM as a back‑up and/or team member and may include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
• Perform quality control of data entry.
• Provide input, assess and manage timelines; ensure clinical data management deadlines are met with quality; assess resource needs for assigned projects as needed.
• Develop CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders.
• Assist in building clinical databases.
• Conduct database build UAT, maintain quality‑controlled database build documentation, and oversee overall database quality.
• Specify requirements for all edit check types (electronic, manual data review, edit checks, etc.) and oversee development of edit check and manual data review specifications.
• Create, revise, version, and maintain data‑management documentation; ensure completeness for the Trial Master File.
• Train clinical research personnel on study‑specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line‑listing data review based on sponsor or Lead DM guidance.
• Run patient and study‑level status and metric reporting.
• Perform medical coding of medical terms to ensure medical logic and consistency.
• Coordinate SAE / AE reconciliation.
• Liaise with third‑party vendors such as external data and EDC vendors in a project‑manager capacity to support timelines and data‑related deliverables.
• Assist with SAS programming and quality control of SAS programs used in the Data Management department.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
• Assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSR) if required by the project.
• Participate in the development and maintenance of SOPs and corresponding process documentation related to data management and database management activities.
• Attend strategy meetings, bid defense preparation meetings, bid defenses, capability presentations, and potential client engagement meetings.
• Review Request for Proposals (RFP), proposals, and provide project estimates.
• Provide leadership for cross‑functional and organization‑wide initiatives, where applicable.
• Train and ensure all data‑management project team members have been sufficiently trained.
• Communicate with study sponsors, vendors, and project teams regarding data, database, or other relevant project issues.
• Present software demonstrations/training, department/company training sessions, and present at project meetings.
• Travel may be required.
• Perform other duties as assigned.

Qualifications

Minimum Required

• Bachelorés degree and/or a combination of related experience.

Other Required

• Experience as a Lead Data Manager for a Clinical Research Organisation.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Ability to handle a variety of clinical research tasks.
• Excellent organizational and communication skills.
• Professional use of the English language; both written and oral.
• Experience utilizing various clinical database management systems.
• Broad knowledge of drug, device, and/or biologic development and effective data management practices.
• Strong representational skills, ability to communicate effectively orally and in writing.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.

Preferred

• Experience in a clinical, scientific or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug).
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
• Oncology and/or Orphan Drug therapeutic experience.