Head of Data Management

1 month ago


Horsham, United Kingdom Cmed Full time

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Denmark, Sweden, UK, US, Romania and Czech Republic.

Through Cmed (a part of the Aixial Group), the CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials for immuno-oncology and cell & gene therapies, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.

We are currently looking for an enthusiastic and talented Head of Data Management. This role can be home-based anywhere in the UK or EU (where we have the legal entity to hire).

**Core Accountabilities**:
Define and implement Cmed’s Data Management and Database programming strategy.

Manage, direct and co-ordinate all activities including project activities, budgets and resources.

Ensure department adherence to QMS and expected delivery KPIs.

Approve departmental processes and lead/contribute to the implementation of systems, processes and standards (e.g. CDISC).

Responsible for department P&L.

**Principal Responsibilities**:
Leadership and oversight

Provide leadership and supervision of staff; lead overall structure in collaboration with Executive Management.

Provide oversight of projects of direct/indirect reports, and program-level management in consultation with Cmed management.

Ensure staff are managed as per Cmed policies.

Ensure timely goals are in place and staff development needs are identified and addressed.

Conduct regular department and one-to-one meetings, and perform staff appraisals.

Recruit, manage, coach and develop members of CDM.

Maintain efficient interfaces with internal and external customers in consultation with Cmed management.

Deputise for other managers in Data & Analytics, as required.

Operational Management

Ensure department meets gross margin targets as per yearly objectives.

Ensure financial indicators are managed accurately at project and department level.

Ensure the consistent delivery of quality clinical trial data to clients within the specified timeframe

Direct resource management across all locations and ensure staff allocation is done in line with project budgets.

Develop, manage and report department KPIs/metrics.

Provide senior consultation within Cmed and/or to Clients with regard to technical reviews and input to clinical trial aspects.

Systems and Processes

Maintain up-to-date knowledge of CDM systems, processes, standards and related regulations.

Identify gaps in processes and compliance risks and ensure corrections are put in place.

In collaboration with the Clinical Data Management Director, lead/support the selection and implementation, or development and improvement, of systems, processes and standards (e.g. CDISC) as required.

Act as expert in clinical data management systems, processes, standards and related regulations on behalf of CDM/CRO Operations.

Business Development

Support business development activities and contribute to the development and growth of business opportunities.

In collaboration with the Clinical Data Management Director, lead and/or contribute to the development of proposals and related Business Development activities as required.

In collaboration with the Clinical Data Management Director, ensure cost models, operational financial indicators and proposals are aligned.

In collaboration with the Clinical Data Management Director, prepare and attend bid defenses; transition knowledge to operational team upon award.

Lead and/or support initiatives for CDM Business Development or CRO-wide activities.

Develop and maintain close positive relationships with counterparts within client organizations.

Other

Other tasks as assigned by Cmed Senior Management.

Additional

The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.

**Essential Work Experience, Qualifications and Knowledge**:
Degree level qualifications or equivalent experience

Extensive knowledge of database design, structures and the handling data from external sources

Experience in the discipline of clinical data management

Extensive experience in leading EDC studies

Significant line management experience

Excellent oral and written communication and presentation skills

Working knowledge of the relationship and regulatory obligatio


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