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Labcorp Drug Development is seeking a skilled professional with a Bachelor of Science degree and over 5 years of experience in science or a related field. The ideal candidate will manage study protocols and communicate efficiently with internal and external stakeholders. Responsibilities include leading quality reviews, scheduling study phases, and participating in training new team members. Strong project management and interpersonal skills are essential for success in this role.
Job Level & compensation offered may vary depending on candidates’ experiences and competencies.
Duties and Responsibilities:
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.
Participates in and is responsible for team report quality peer review
Leads aspects of communication and interaction 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.
Demonstrated ability to independently lead study progress monitoring
Serves as a backup PI/SD on project management tasks
Schedules study phases in coordination with SD/PI and lab operations.
Ability to lead 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.
Independently owns and manages process improvement initiates, or non-study related projects
Learns to serve as a backup to management team with regards to non-personnel related management responsibilities.
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 and is able to lead routine client visits as requested.
Participates in the training of new team members
Performs other related duties as assigned
Principal Contacts
Internal - Interacts with internal staff responsible for study management. In addition, interacts with internal operational and scientific personnel and the management of these areas.
External –Interacts with clients, subcontractors, research facilities and regulatory agencies.
Required Education/Qualifications:
Bachelor of Science (BS) degree in science or related field.
Experience may be substituted for education.
Ability to utilize word processing software, database, spreadsheet, and specialized software.
Required Experience:
Minimum of 5 years of related experience.
Excellent communication, presentation, and interpersonal skills.
Excellent attention to detail.
Ability to prioritize and manage time.