Description
Our client, a globally recognised brand, are currently recruiting for a Study Project Lead to work in Macclesfield, Cheshire for a pharmaceutical end client.
There are two positions available. One for a 6 month period and one for an 11 month period.
To be responsible for project management activities for assigned therapeutic area trials in the area of clinical data management, Statistical Programming, Analysis and Medical writing. Also, to ensure that all activities are completed to an agreed timetable
QUALIFICATION:
- Graduate/Post-Graduate degree in/Pharmacy/Life sciences preferred
- Over 8 years of total experience with Cognizant or equivalent experience in another organization including over 4 years in the clinical trials environment.
SKILLS/PERSONALITY
- Ability to lead multi-functional teams
- Capable of planning and managing multi-centre, multi-national clinical trials with minimum supervision
- Experience of working within the clinical research environment
- In depth knowledge of the clinical research process, Good Clinical Practice and relevant legislation
- Relevant work experience within the Pharmaceutical or allied Industry
RESPONSIBILITIES
- To ensure that all activities are completed on time for assigned projects by allocation of tasks and effective management of relevant stakeholders; clinical teams and data management centre
- To schedule assignments within area of responsibility so that overall project deadlines are met and keep management informed of progress and problems associated with the workload.
- To participate on interdisciplinary teams concerned with all aspects of clinical trial management and to deputise for the Clinical Research Manager at interdepartmental strategy groups, if required.
- Orchestrate the activities and deliverables of all stakeholders (SA,SP, MW and DP) to ensure timely delivery of quality data on one or more studies
- Responsible for ensuring that studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements
- To assist the Clinical Research Manager/study teams with respect to audits and regulatory Authority Inspections. Develop project plans and implement resource strategies to achieve team's project goals, including contingency planning and risk mitigation strategies, to ensure successful delivery of study goals.
- Facilitate coordination and study level activities
- Share best practices across the organization to ensure cross-line standardization
- Support the efficient implementation and utilization of globally agreed processes, technologies and strategies to ensure consistent processes are used across studies
- May coach and mentor as appropriate
- Contribute to meeting strategy/agenda and responsible for overseeing implementation by the appropriate group (eg, MW, SP, SA and DP); review meeting objectives/materials.
- Track progress to ensure all essential study related materials, equipment and documentation are in place for study start
- Work closely with study team to ensure data quality requirements are agreed to and met, prior to reporting.
- Analyze error trends and provide feedback to enable continuous Improvement.
- Overall accountability for the quality and completeness of Trial Master File and any additional regulatory documentation.
- Work with transactional quality to establish appropriate QC, audit and inspection plans. Central point of contact for site and sponsor audits. Support the writing of appropriate audit responses and ensure actions are completed.
Suitable candidates should submit their CV at the first instance