Systems Implementation Leader

Welwyn Garden City
£400 per day
29 Jul 2019
28 Aug 2019
Stephen Lord
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Steve Lord is recruiting for a Systems Implementation Leader to join a global biotechnology company at their site based in Welwyn Garden City on an initial 12 month contract basis.

The main purpose of the role will be to act as the primary point of contact and business partner for study management teams for all clinical systems and services.  You will be accountable for the set up, implementation and operations of the clinical operations systems such as IxRS, eCOA, CTMS, eTMF, RBM, EDC and clinical supply systems.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Knowledge of clinical operations processes and information systems such as IxRS, eCOA, CTMS, eTMF, RBM and EDc.
- Experience managing 3rd party vendors to deliver quality service.
- Ability to see and predict relationships between systems and procedures in projects and understand their interdependencies.
- Broad knowledge of applied GxP in pharmaceutical or biotech industry.
- Previous experience in clinical trial planning and execution.
- Able to lead teams or change initiatives through to implementation - able to navigate organisational complexities.
- Business partner & stakeholder management experience.
- Business needs analysis.
- Problem solving skills and able to drive results through to completion.

Main duties:
- Be accountable to, and partners with the SMT and relevant 3rd parties to lead, direct, and efficiently deliver clinical systems and innovative solutions, in support of clinical trials.
- Manage the end-to-end lifecycle of applicable clinical systems needed for a given study, including requirements gathering and reviewing, testing, deployment, maintenance, and closeout.
- Understand business context and SMT goals to effectively partner with and continually assesses the needs of the SMT, to proactively translate business needs into system and process improvements.
- Serve as first line of contact for triaging all SMT support and service requests for each clinical study.
- Ensure prompt resolution of system issues, and provides timely and accurate responses to customers, as defined in service level agreements.
- Proactively collaborates with other sub-functions and beyond, to identify business needs and/or issues, and provides solutions to SMTs.
- Monitor clinical system key performance indicators (KPIs) and contributes to analysis to identify root causes for defects, to recommend process and/or system improvements.
- Identify process inefficiencies and compliance gaps, participates in process improvement initiatives and drives process implementation in support of SMTs.
- Develop strong relationships and maintains effective communication within group, as well as other functional departments within the company in support of business goals and improvements.
- Report into the Operations Study Team Support (STS) Manager.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group 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 46168 in all correspondence.

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