Associate Clinical Study Manager (San Antonio, Tx)

Worldwide Clinical Trials · United States

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Associate Clinical Study Manager does at Worldwide The Associate, Clinical Study Manager will be responsible for the site-level monitoring activities of on one or more allocated Phase I through IV Clinical Trials that may be local, regional, or global in scope. Supports the CSM with directing the technical, financial, and operational aspects to ensure the successful completion of the clinical trials. Works with functional area leads to identify and evaluate essential project prerequisites. The ACSM cooperates with the CSM to ensure all project deliverables meet client’s time/quality/cost expectations. What you will do

• Coordinate study monitoring visits, to include (but not limited to): ensuring the monitor has access to the relevant electronic systems, reserving monitoring space, assembling study documents for CRA review, and ensuring all follow-up action items are completed in a timely manner.
• Work collaboratively with other clinic departments to ensure all queries are answered in a timely manner.
• Manage and store signed approval forms for Clinical Lab, PK processing, Clinspark Go live, and Clinspark training and access request forms from clients.
• Coordinate and collate signature forms for SIV attendance, logistics meetings, and any other protocol training related meetings, file in the appropriate study folder.
• Ensure staff training is documented in the appropriate study files on the study protocol and other related processes, adhere to professional standards and to SOPs as well as current Good Clinical Practice (GCP) and applicable local regulations.
• Facilitate shipment of samples to bioanalytical labs for analysis per the study timeline and/or client request.

• Excellent communication, planning, and organizational skills.
• Sense of urgency and ability to be adaptable in a fast-paced and rapidly changing environment.
• Self-motivated and excellent problem-solving skills.
• Ability to work independently.
• Ability to negotiate and liaise with clients in a professional manner.
• Must have satisfactory customer service skills.