Principal Data Manager Onsite (Preferred)or Home based within UK
We have an amazing opportunity working with one of our clients as a Principle Data Manger who are a clinical research organisation based in Europe.A mid-sized CRO they help in providing services to clinical study reports for clinical trials ranging from Phase I-IV and medical device testing. They specialise in data management, biostatistics, programming and analysis.

Here's an idea of what you will be doing:

• Lead and drive the DM team, acting as mentor and coach
• Act as the reference point for the Sponsor and the appointed person responsible for the project from the Data Management perspective, to develop the data collection specification from all data sources
• Manage in-stream data flow activities and deliver a quality database in accordance with the project plan
• Ensure DM tasks for the assigned studies are performed on time and within budget
• Make recommendation for process improvement and/or new standards development
• Effective input into strategic planning across the department
• Bridge scientific or medical knowledge to data management processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets

Accountabilities:

• Accountable for driving achievement of project milestones from study start up through to delivery of database;
• Provide Data Management input into the protocol
• Design the Case Record Form and guide process for CRF approval
• Define and develop the Data Management Plan, with input from the study team
• Validation of the database and computerized checks, including SAS listings or SAS checks
• For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF
• For EDC studies, re-act to issues identified by the eCRF Helpdesk
• Prepare CRF completion guidelines
• Prepare study specific data-entry guidelines and train data-entry staff
• Perform term cleaning for clinical studies, raise manual queries for uncoded terms as required
• Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listings
• Create and test import programs for electronic data received from external vendors
• Perform timely data integration of CRF and non CRF data (data import from external sources)
• Perform reconciliation of external data (e.g. SAE, Central Labs, ECGs etc)
• Run and monitor study data progress reports including query management
• and take appropriate actions (e.g. escalation, re-training, etc), escalate any study issues within study team
• Define and executive QC plan, lead and execute database release and database freeze activities
• Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and proritising
• Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level
• Proven ability to analyse data capture problems/opportunities and a track record of developing and delivering high quality solutions
• Conducts other activities as required

You should recognise yourself here:

• Degree in life science, pharmaceutical, biology or related field in a pharmaceutical environment CRO experience preferred.
• Knowledge of Data Management processes,
• Knowledge of pharmaceutical industry guidelines like ICH, GCP etc, Very Good
• Expert in one or more DM systems or processes and recognized for your expertise
• Able to propose standards across studies and therapeutic areas
• English Excellent written and spoken
• Presentation skills
• Ability to communicate effectively within project arena
• Experienced supervisor of DM staff and coordinate workloads,
• Ability to build effective working relationships across functions and levels, and to manage those relationships with positive outcomes

Please ask for full details

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