Clinical Data Management Manager
Paul De Challans is recruiting for a Clinical Data Management Manager to join a global pharmaceutical company at their site based in Greater London on a contract basis.
The main purpose of your role as a Clinical Data Management Manager will be to:
- Project manage Data Management (DM) activities for all studies within a product/therapeutic indication from Protocol review to Database Lock.
- Oversee a number of lead data managers working on studies within a drug area to successfully meet all deliverables, on time, and to a high standard of quality.
- Ensure that DM procedures and processes are adhered to and meet business requirements.
- Be accountable for meeting study/project timelines.
- Lead DM activities for assigned project teams.
- Communicate within their assigned product teams globally and cross-functionally.
- Review all study related documents within a project area, ensuring consistency, quality and accuracy of content.
- DM representation on assigned project teams e.g. Global Clinical Study Team.
- Lead/participate in DM process improvement forums, as required.
- Project level resource management in conjunction with Senior Manager DM.
- Lead electronic submission activities.
- Oversee selection of insourcing/outsourcing partners for assigned studies including: *Input to Request for Proposal (RFP) *Review of insourcing/outsourcing partners' proposals *Participate in insourcing/outsourcing partners' evaluation/audits *Participate in insourcing/outsourcing partners' presentations *Review project scope of work documentation
- Assist with response to questions and findings from Clinical Quality Assurance (CQA) and other departmental audits
- Participate in development and review of policies, SOPs and associated documents for DM
- Attend relevant focus group and committee meetings e.g. Clinical Data Interchange Standards Consortium (CDISC), Association for Clinical Data Management (ACDM/SCDM) etc.
- Maintain and improve global collaboration within DM and associated functions.
- Promote and be an advocate of DM internally and externally;
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Demonstrated strong project management, leadership and strategic sourcing experience are essential
- Robust pharmaceutical/CRO industry experience within a Clinical environment
- In depth knowledge of ICH/GCP and a thorough understanding of the drug development process.
- Excellent negotiation skills and diplomacy to enable facilitation of issue resolution with key internal Stakeholders and clients.
- Highly motivated, enthusiastic and driven.
- Excellent written and verbal communication skills with ability to proactively share and present ideas in a one to one or group setting.
- Ability to plan, organise and prioritise appropriately.
- Excellent analytical and problem solving skills.
- High attention to detail.
- Capability to work to deadlines in a fast paced environment.
- Ability to work without supervision.
- Deliver effective communication to all interested parties, Including stakeholders and the leadership Team to support effective decision-making and manage the smooth and integral delivery of any new process.
- Experience working with external suppliers.
- Experience working in a Functional Service Provider (FSP) model.
- Use/oversight of EDC systems. This is an excellent opportunity to join a Global Pharmaceutical company
For more information or to apply for this position, please contact Paul De Challans on 0114 283 9956 or firstname.lastname@example.org. Alternatively please click on the link below to apply online.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL29845 in all correspondence.