COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We are recruiting for our Early Compound Development Unit team in Harrogate and are currently seeking to hire a Senior Study Coordinator – Metabolism to help support the metabolism-Study Direction team to conduct all work in compliance with appropriate company standards, GLP, GCP, GMP (where appropriate) and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved.
This is a full time permanent position, based in our site in Harrogate.
Individual has a responsibility to conduct all work in compliance with appropriate company standards, GLP, GCP, GMP (where appropriate) and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved.
Essential Job Duties:
- Drafts protocols, amendments and study schedules as appropriate using study outline or client supplied information
- Reviews study compliance against protocol, SOP and regulatory agency guidelines
- Prepares study schedules based on input from Study Director (SD)/Principal Investigator (PI), places information into databases and communicates work plan to laboratory personnel and support groups, as applicable.
- Participates in and assists SD/PI with pre-initiation and other study related meetings as required
- Reviews progress and study status against initial work plan – maintains CMS with accurate schedules.
- Proactively communicates and interacts with study team (SD’s and operational staff) to ensure key milestones are achieved
- Serves as the primary contact in communication and interaction with other departments and clients as applicable
- Maintains well documented, organised and up-to-date study files including study schedule, protocol and correspondence.
- Assists SD/PI in monitoring in-life and analytical phases of studies, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines.
- Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.
- Develops new report/table formats as needed including client specific formatting. Maintains and updates existing templates as necessary.
- Assists SD’s/PI in writing portions of the report involving scientific interpretation as appropriate
- Contribute to the peer review process for scientific reports, providing constructive feedback as appropriate.
- Reviews QAU report audits with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.
- Reviews client comments and makes decisions in conjunction with SD/PI and ensures that all necessary report/raw data clarifications are completed.
- Regularly manages increasingly more complex projects and study designs and/or increased study load
- Deputises for SD in their absence with ability to provide updates to internal/external customers
- Responsible for and drives report production through finalisation, including archiving of data as appropriate.
- Prepares for and participates in routine client visits under direction of the SD/PI. Hosts routine client visits and interacts/communicates with client as necessary.
- Maintains an awareness of the financial status of ongoing studies, including workscope changes
- Develops an area of expertise within the department and serves as a resource by providing training an written instructions
- Ability to competently coordinate (without supervision) across the entire metabolism portfolio
- Acts as a project coordinator for assigned clients(s) across the metabolism discipline
- Leads and/or participates in improvement projects to increase the efficiency of routine procedures and reporting methods
- May act as Principal investigator, Responsible Analyst or Study Director on specific projects within area of expertise
- Trains and directs less experienced staff in the conduct of coordination tasks and helps resolve issues
- Able to review work of others for overall accuracy, timeliness, completeness and soundness of technical judgment.
- Performs other related duties as assigned.
- Consistently and continuously responds efficiently to requests (delivers high quality output on time)
- Motivates self and others to assure timely delivery of client expectations
- Influences others to see things from a clients perspective
- Awareness of latest technologies and regulatory thinking with respect to specific scientific discipline. Advises Study Directors and management where modifications to working practices are necessary
- Uses experience to apply creative problem solving to challenging issues
- Guides and coaches others through the process of change and addresses obstacles and resistance
- Follow instructions, SOPs and protocols that apply to current role to complete assigned tasks and projects
- Anticipates, detects and promotes quality and process improvement needs in own and others areas
- Shares and promotes expertise internally
- Actively promotes collaboration between groups
- Provides team leaders and members with regular supportive feedback
- Promotes constructive behaviours
- Establishes clear plans to meet short and medium term requirements for projects
- Anticipates issues/obstacles which may prevent meeting project/department objectives and identifies solutions to overcome difficulties
- Ability to recognise deviations from normal results and inform Study Director, Study Coordinator and/or management of any problems that may affect integrity of the data
- Ability to devise and implement action plans for a study or complex method development
- Ability to understand the scope of a study (primary area of work) and be able to complete with no supervision
- Recognised as SME in a key process or specific operational area