|Location: Cambridgeshire||Salary: £450 - £500 per day|
|Sector: Pharmaceuticals, Medical Communications, Medical Devices, Life Sciences||Type: Contract|
|Contact: Zak Mendoza||Job Published: 16 days ago|
Principal Clinical Study Data Manager
Cambridgeshire (Remote Working)
Principal Clinical Study Data Manager needed for a highly reputable and respected Pharmaceutical organisation based in Cambridgeshire who are looking to employ an experienced and well-rounded Principal Clinical Study Data Manager that takes pride in their work solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry, demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements and demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC).
What the role entails:
Some of the main duties of the Principal Clinical Study Data Manager will include:
- Coordinate the Clinical Data management deliverables on assigned projects depending on the relevant model and DM Vendor. Takes accountability and serves as the first line of contact at the project level.
- Demonstrates leadership and operational knowledge in the planning and delivery of CDM deliverables at a project level under mentorship from a Principle Clinical Project Data Manager.
- Communicates and collaborates effectively with all project level team members. Primary point of contact for DM vendor and provides guidance and supervision to Lead Data Manager/DM Team Lead working on the project (CRO or in-house).
- Oversight of the day to day operational aspects of CDM for assigned projects; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risk.
- Understands therapeutic area, indication or program specific data capture standards and AZ standards.
- Provide input into CDM related activities associated with regulatory inspections/audits for assigned project(s).
- May provide input to the selection and use of software systems, devices and vendors.
- Responsible for compliance to Trial Master File requirements relating to DM Vendor
- Support Senior Leaders to oversee CDM Vendor performance, depending on relevant model. Review, assess and manage DM Vendor delivery against KPIs, budget and overall performance. Oversees vendor timelines and milestone deliverables for the assigned projects. Ensures DM Vendor billing is accurate and gives recommendations for payment of invoices.
- Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned project(s).
- Maintain an awareness of the external and internal models in order to participate in change initiatives and continuous improvement activities related to CDM operating models.
- Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM.
- Mentoring junior Clinical Data management colleagues
What experience you need to be the successful Principal Clinical Study Data Manager
- University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree
- Solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry
- Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
- Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
- Demonstrate understanding and experience in query management process and reconciliation activities
- Good communication and interpersonal skills including effective problem solving
- Ability to work independently without close supervision
- Excellent written and verbal communication skills
- Ability to work in a global team environment
- Excellent organizational and analytical skills and high attention to detail
This really is a fantastic opportunity for a Principal Clinical Study Data Manager to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!
Services advertised by Gold Group are those of an Agency and/or an Employment Business.