职位描述
Job Summary:
Independently performs activities related to Project management process by coordinating activities for routine studies in compliance with appropriate protocol, Standard Operating Procedures (SOPs) and regulatory agency guidelines, in a timely, efficient, and quality manner.
Essential Job Duties:
Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules with some oversight, using proposal outline or client-supplied information.
Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
Responsible for data table compilation including quality review oversight and data table transfer.
Communicates and interacts with study team, other departments and clients as applicable.
Serve as the primary contact in communication and interaction with other departments and clients as applicable.
Proven ability to plan, prioritize and manage workload and multiple responsibilities.
Demonstrated ability to independently use project tracking systems as appropriate.
Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence as applicable.
Assists SD/PI in monitoring study progress.
Serves as a backup PI/SD on project management tasks
Schedules study phases in coordination with SD/PI and lab operations.
Proven ability to participate in and assist Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
Proven ability to manage increasingly complex projects and study designs and/or increased study load.
Demonstrated capability to manage work for key clients.
Demonstrated ability to support and be involved in process improvement initiates and endeavors
Reviews QAU report audits. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
Assists with routine client visits as requested.
Performs other related duties as assigned
Assists in setting up and performing method development and validation of various analytes in a variety of matrices.
Performs complex analyses using unfamiliar or new methods, asking for scientific guidance as needed.
Makes suggestions for modifications in test methods or procedures
Education/Qualification
BS/BA degree in science plus at least 4-5 years experience or MS degree with 2-4 years experience.
®Efficient use of word processing software, database, spreadsheet, and specialized software.
®Proficient in concise writing. Writing should require little or no external review or edit.
®Adherence to grammar, punctuation, composition, and spelling according to company standard conventions.
®Experience on a variety of studies performed in the department and exposure to a diverse client base.
®Knowledge of regulatory agency guidelines.
Experiences:
Two years of study coordinator for large molecule or related experience.
®Excellent communication, presentation, and interpersonal skills.
