Ref #: 25601

Employment type: Permanent - Full-Time

Location: Poland (HB or Office-based)

Posted: 24-Dec-2020

Description

Job Details:

The role of the Study Data Manager will provide complete oversight of a given project or projects and is responsible for leading and coordinating the end-to-end quality deliverables of data management activities for clinical trial including study set-up, conduct and closeout. The SDM is also responsible for execution of Data Management (DM) activities per set timelines with quality and consistency and will provide comprehensive data management expertise and support to study team members cross functionally.



Responsibilities include:

Ensuring clinical projects are executed according to set timelines with quality and consistency
Leading DM activities for a given project or multiple projects
Ensuring that DM procedures and processes are adhered to by FSP staff through oversight of quality, cycle times, metrics and use of the Issue CAPA process
Co-ordination of associate SDM (aSDM) within assigned projects


Key Activities:

Responsible for the project deliverables such as:
Planification of all data management activities, considering the overall study timelines
Protocol review and defining data collection strategy
eCRF design and review
Defining data cleaning and validation strategy integrating risk-based approach
Data Management Plan and Centralized Monitoring Plan
Review of all other DM documents within a project area to ensure a consistent approach
Coordinating vendor external data activities: load, integration activities and reconciliation activities, including External Lab data, eCOA, IRT integration etc.
Database locks and unlocks
Actively monitor progress of clinical projects within assigned product area to ensure delivery to set timelines and quality standards
Represent DM at study team meetings
Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc..
Co-ordination of aSDM within the project
Develop QC strategy and ensure that quality control checks are occurring such that quality databases are delivered
Oversight of FSP vendors with respect to quality, Issue & CAPA tracker & KPI metrics
Manage vendor deliverables and relationship at the project level
Review of all study level non DM documents for awareness and project level consistency
Lead electronic submission activities
Assist with response to questions and findings from Clinical Quality including participating in project level audit
Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM
Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education
Promote and be an advocate of DM internally and externally


Qualification and Skills:

6+ years work experience in data management in the Pharmaceutical or Biotech area
3+ years project management and planning experience
Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.)


Preferred Qualifications

Bachelor’s degree or above in life science, computer science or related discipline


What is offered

Competitive salary
Home based or office-based (Warsaw)
Permanent Position



If you are seeking an international company who is committed to development and training and the opportunity for career progression, please get in contact.

#datamanagement #datamanageropportunity