Senior Clinical Data Manager / Principal Clinical Data Manager Remote, Spain

Senior Clinical Data Manager / Principal Clinical Data Manager

Remote, Spain

Position Summary :

The Senior Clinical Data Manager / Principal Clinical Data Manager is responsible for managing 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. This is a remote position; candidates can be based in one of the following countries : UK, Spain, Hungary, Poland, Romania, Serbia, or Slovakia.

Essential functions of the job include but are not limited to :

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and / or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality, and resourcing.
• May perform quality control of data entry.
• Provide input, assess, and manage timelines. Ensure that 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 the review / feedback from all stakeholders.
• May assist in building clinical databases.
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g., electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications.
• Responsible for creating, revising, appropriate versioning, and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the 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 the guidance provided by the sponsor and / or Lead DM.
• Run patient and study level status and metric reporting.
• Perform medical coding of medical terms relative to each other to ensure medical logic and consistency.
• Liaise with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables.
• May 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.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs), if required by the project.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings.
• May review Request for Proposals (RFP), proposals, and provide project estimates.
• Provide leadership for cross-functional and organization-wide initiatives, where applicable.
• Train and ensure that all data management project team members have been sufficiently trained.
• Communicate with study sponsors, vendors, and project teams as needed regarding data, database, or other relevant project issues.
• May present software demonstrations / trainings, department / company training sessions, and present at project meetings.
• May require some travel.
• Perform other duties as assigned.

Qualifications : Minimum Required :

• Bachelors and / or a combination of related experience.

Other Required :

• Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company.
• Proficiency in Microsoft Office : Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of clinical research tasks.
• Excellent organizational and communication skills.
• Professional use of the English language; both written and oral.
• Experience in utilizing various clinical database management systems.
• Broad knowledge of drug, device, and / or biologic development and effective data management practices.
• Strong presentational 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.