Ref #: 28169

Employment type: Permanent - Full-Time

Location: Home Based in Germany

Posted: 13-Apr-2021

Description

Summary:

DOCS has partnered with a highly prestigious organization with one of the most robust pipelines and a proven track record as one of the most liked employers in the pharmaceutical industry. We are looking for interested Data Managers in Germany who want to become a part of this family and add to the success story.


Roles & Responsibilities of the position:

The Senior Lead Clinical Data Manager will be responsible for managing data management support, oversight and accountability for clinical trials with focus on DM CRO and third party data vendor management and oversight.

Key Responsibilities:

• With the trial customer, CRO and other functional partners:
o Gathers content and integration requirements for eCRF and other data collection tools.
o Establishes conventions and quality expectations for clinical data.
o Establishes expectations for dataset content and structure.
o Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.
• Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction.
• Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
• Ensures real-time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and internal audits as necessary.
• Takes a leadership role in planning and tracking content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.
• Takes a leadership role with the assigned clinical working group(s) to ensure that Data Management and TA trial needs and deliverables are met.
• Presents and trains at investigator and monitor meetings if needed.

Job Requirements:

• Bachelor’s degree or equivalent in Health or Science discipline with experience in clinical research.
• 3 or more years of experience Lead Data Manager function
• End to end data management experience (Study Start–up, setup, conduct and DB Locks) and also Vendor / CRO Management and oversight experience in clinical research.
• Excellent project, stakeholder and vendor management skills
• Vaccine experience highly preferred
• Advanced Microsoft Office skills including the ability to manipulate and analyze data
• Highly organized with excellent written and verbal communication.
• Ability to interpret clinical trial data and present trends to clinical trial team on data


What is offered:

• Opportunity to be part of a TOP 10 CRO and working on secondment for a TOP Pharma company - working to their processes, SOPs and on their systems.
• 100% Home Based.
• Full time permanent contract.
• Great work atmosphere.
• Contribution to pension scheme.
• Opportunity to further develop data management, project management, and oversight skills and experience.



To apply:
You have what it takes and you would like to know more? Please submit your CV to timo.kindermann@docsglobal.com or via our homepage www.ICONplc.com/FSP. We are looking forward to getting to know you.

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