Individual has responsibility for coordinating the activities of routine and non routine studies for one business line (Noncompartmental analysis) in compliance with appropriate company standards, GLP, GCP, GMP and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient and quality manner.
- Trains and mentors less experienced staff
- Able to review work of others for overall accuracy, timeliness, completeness and soundness of technical judgment.
Essential Job Duties:
- Performs initial review of analytical data and originates noncompartmental analysis in support of pharmacokinetic and toxicokinetic studies
- 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 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 the PK/TK (Pharmacokinetics Toxicokinetics )study phase, 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.
- Assists in the development and maintenance of standard report/table formats as required
- Assists in interpreting and evaluating data for reports
- Participates in the peer review process for scientific reports
- 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.
- Learns to deputise for SD in their absence with ability to provide updates to internal/external customers
- 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
- Responsible for and drives report production through finalization, 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
- Develops knowledge of Covance metabolism capabilities such that they can coordinate (with supervision) one other area outside of their area of expertise
- Learns to expand responsibilities as a project coordinator for assigned clients(s) across the metabolism discipline
- Performs other related duties as assigned.
- Consistently and continuously responds efficiently to requests (delivers high quality output on time)
- Builds positive relationships with both internal/external clients
- Evaluates and develops new approaches, ideas and concepts for existing tasks and to improve or replace existing procedures
- Uses experience to apply creative problem solving to challenging issues
- Shifts ideas and behaviors to keep pace with changing business needs
- Follow instructions, SOPs and protocols that apply to current role to complete assigned tasks and projects
- Assists in evaluating the effectiveness of current practices and contributes ideas for solutions to prevent errors and improve efficiencies
- Remain up to date in area of knowledge and continuously improve technical and interpersonal skills
- Improves team performance through realistic planning and open constructive feedback
- Helps colleagues adapt to changes and provides encouragement and long term support
- 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 recognize deviations from normal results and inform Study Director and/or management of any problems that may affect integrity of the data
- Ability to recommend modifications to routine procedures to adapt to problems in primary area
- Ability to understand the scope of a study (primary area of work) and be able to complete with no supervision on at least one study type.
Relevant degree plus 4 years of appropriate experience. Relevant experience may be substituted for academic qualifications.
At least 18 months at previous level
- Ability to utilise word processing, databases, spreadsheets, and specialised software on personal computers.
- Skilled in the use of all standard laboratory equipment
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