Full-Time Lead Data Manager

PSI CRO is hiring a remote Full-Time Lead Data Manager. The career level for this job opening is Manager and is accepting Europe based applicants remotely. Read complete job description before applying.

PSI CRO

Job Title

Lead Data Manager

Posted

Career Level

Full-Time

Career Level

Manager

Locations Accepted

Europe

Job Details

The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects.

Communication:

  • Primary communication point for project teams and company departments with regard to clinical data management
  • Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting

Data Management:

  • Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables.
  • Primary responsibility for clinical data management activities within clinical projects, including:
    • Study documents review
    • Data Management plan and other project-specific guidelines and instructions development and review
    • Co-ordinate/perform user acceptance testing
    • Development of Data Validation Plan/Edit Check Specifications
    • Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues
    • Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data
    • Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)
    • Database edits (paper CRF studies)
    • Manual CRF review (non-medical checks)
    • Clinical database lock
    • Coordination and supervision of processing, dispatch and archiving of CRFs/queries
    • Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
    • Development of CRF completion guidelines
    • Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
    • SAE reconciliation
    • Electronic data transfer (import/export) specifications review and approval

Document Management:

  • Liaison with Document Center with regard to maintenance of TMF and eTMF

Quality Control:

  • Database QC checks performance and documentation
  • Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
  • Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management

Training:

  • Training of Assistant Data Managers
  • Project-specific training of investigators and clinical team in CRF completion

Corporate/Departmental Assignments:

  • Investigator Meetings preparation/attendance
  • Meetings and teleconferences organized by client/vendor preparation/attendance

Qualifications:

  • College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
  • At least 3 years of experience of full scope of data management responsibilities in international EDC studies
  • At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
  • Project data management experience is a plus
  • Full working proficiency in English
  • Organizational and managerial skills

Additional Information:

  • Advance your career in clinical research and develop new skillsets whilst growing with the organization.

FAQs

What is the last date for applying to the job?

The deadline to apply for Full-Time Lead Data Manager at PSI CRO is 10th of January 2025 . We consider jobs older than one month to have expired.

Which countries are accepted for this remote job?

This job accepts [ Europe ] applicants. .

Related Jobs You May Like

Director of Biostatistics

Denver, CO
2 days ago
Clinical Trial Design
Data Analysis
Drug Development
Sobi
Full-Time
Experienced

VP, Clinical Research Science

USA
2 days ago
Clinical Research
Clinical Trial Management
Process Improvement
IMVT Corporation
Full-Time
Manager
YEAR $320000 - $350000

Medical Monitor (Gastroenterology)

Budapest, Hungary
3 days ago
Clinical Trials
Data Analysis
GCP
PSI CRO
Full-Time
Experienced

Associate Director, Regulatory Affairs

Waltham, MA
3 days ago
Clinical Trials
Drug Development
Oncology
Deciphera Pharmaceuticals
Full-Time
Manager

Medical Monitor (Nephrologist)

Remote
4 days ago
Clinical Research
Communication
Data Analysis
PSI CRO
Full-Time
Experienced

Interviewer (German Speaking)

Gothenburg, Sweden
4 days ago
Cold Calling
Communication
Market Research
M3USA
Full-Time
Experienced

Clinical Trial Business Development Representative

King of Prussia, PA
5 days ago
Clinical Research Sales
Communication Skills
CRM Systems
PSI CRO
Full-Time
Experienced

Director, Business Development - Southeast

Raleigh, NC
5 days ago
Business Development
Client Management
Communication
Ergomed
Full-Time
Experienced

Specialist, Regulatory and PV Network

Warsaw, Poland
6 days ago
Client Relationship Management
Communication
Problem Solving
Ergomed
Full-Time
Experienced

PV Physician II

Sofia, Bulgaria
1 week ago
Communication Skills
Literature Review
Medical Review
Ergomed
Full-Time
Experienced

Grants Expense Management Coordinator

São Paulo, Brazil
1 week ago
Budgeting
Clinical Trials
Data Analysis
PSI CRO
Full-Time
Experienced

US Medical Advisor/Manager

Woburn, MA
1 week ago
Communication
KOL Management
Medical Affairs
Sirtex
Full-Time
Manager
YEAR $200000 - $226000

Looking for a specific job?