- Duties and Responsibilities:
- Performs day-to-day technical management of studies with occasional mentorship and guidance management to develop general expertise in the field.
- Responsible for the design, conduct and reporting of studies to meet scientific, regulatory and client requirements. (Studies will be of intermediate complexity in design and scope)
- Reviews technical validity of projects and results with occasional help from more experienced scientists.
- Evaluates data for report preparation and experiment modification, as applicable and writes comprehensive reports.
- Project management responsibilities, including: client interaction.
- Co-authorship of scientific papers and posters.
- Adds basic understanding of scientific knowledge to assigned projects.
- Learns to manage client relationships for research projects.
- Maintains positive control over timing and scheduling issues related to the study process.
- If acting as a PI, consults with Study Director to determine project requirements. Suggest and/or guide plans to accomplish these requirements.
- If acting as a Study Director, consults with PI to finalist project requirements with client.
- Supply information to assist in the preparation of the preliminary cost and duration discussions.
- Prepares feasibility/development, validation protocols and/or sample analysis outlines as required.
- Partners with Study Coordinators to prepare and communicate appropriate documents to clients for approval.
- Explains scientific performance expectations to scientific staff and directs study team at study initiation, communicates final protocol or sample analysis outline.
- Monitors/evaluates/reviews the scientific performance of the study. Provides clients with regular progress updates.
- Initiates, reviews and approves (as appropriate) protocol deviations and study communication forms.
- If acting as a PI, discuss project issues or scope changes with the Study Director, suggest solutions and action to solve study issues, manages the impact on time and cost, reviews protocol changes and communicates the status of changes to client and management as necessary.
- Participates in post project assessments by providing input on team performance.
- Participates in, and may host, client visits.
- Assures on-time delivery of high quality data and reports.
- Assures that the final report, including any changes, is approved and in compliance with appropriate SOPs and regulatory agency guidelines.
- Provides relevant information to assure accuracy of forecast and revenue recognition.
- Participate in CAIR discussions.
- Contribute to technical policies, such as SOPs.
- Perform other duties as assigned.
Bachelors of Science (BS) degree in science required.
PhD degree desired (additional experience not required with a PhD).
Experience may be substituted for education.
Knowledge of GLP and regulatory guidelines.
Proficiency in project management skills.
Ability to conduct literature review.
Skilled in data interpretation and report writing for studies
A minimum of 7 years related experience in a laboratory environment, 3 years within the designated field of position
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