Study Manager

Altasciences•Overland Park, KS

11d

About The Position

The Study Manager is responsible for the overall supervision, coordination and management of assigned clinical trials in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs).

Requirements

High School diploma or GED and related job experience required
Excellent written and verbal communication (French and English at the Montreal location)
leadership and organizational skills.
Customer service focused
able to work in a fast-paced environment.

Nice To Haves

college degree preferred

Responsibilities

Ensure the confidentiality of clinical trial participants and sponsors is respected.
Supervise and/or oversee all study related procedures.
Act as a resource to indirect reports as well Clinical Operations team members.
Oversee trial progression and communications in regard to the trial’s progression to clients, internal departments, etc.
Participate in protocol and ICF reviews.
Coordinate operations to meet protocol requirements and pre-defined study timelines. Pro-actively define any needs required to accomplish timelines.
Ensure the creation of study specific SOPs, trainings or other materials as needed for study specific procedures.
Conduct protocol trainings and/or coordinate any required training(s) on study specific procedures.
Ensure On-site file(s) are complete and accurate.
Approve staffing designs and review staffing schedules to ensure sufficient staffing requirements are met based on protocol needs.
Assure the study Investigational Product (IP) is received and dispensed in lieu with study timeline requirements.
Participate in SOP revisions.
Prepare for, participate in and/or act as a liaison for audits conducted by study sponsors, Quality Assurance (QA) and regulatory agencies.
Coordinate study monitoring. This may include but is not limited to: communications with the monitor, providing study source, responding to monitor queries and coordinating monitor visits.
Perform protocol specific activities.
Record adverse events and concomitant medication use and follow-up on open adverse events until resolution.
Obtain and document study related events and data in compliance with GCP/SOPs.
Track enrollment status and appropriate document enrollment changes.
Review of subject eligibility for participation.