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Bioanalytical Study Manager information

What does a bioanalytical study manager do?

A Bioanalytical Study Manager oversees the planning, execution, and reporting of bioanalytical studies, which are essential for drug development and regulatory submissions. They coordinate laboratory activities, ensure compliance with regulatory guidelines such as GLP (Good Laboratory Practice), and manage timelines and budgets. Their responsibilities also include liaising with clients, scientists, and other stakeholders to ensure high-quality study results and successful project completion.

What are the key skills and qualifications needed to thrive as a bioanalytical study manager?

To thrive as a Bioanalytical Study Manager, you need a strong background in life sciences, analytical chemistry, or pharmacology, often supported by a relevant degree and experience in regulated laboratory environments. Familiarity with bioanalytical techniques (such as LC-MS/MS), compliance with GLP/GCP standards, and proficiency in laboratory information management systems (LIMS) are typically required. Excellent organizational skills, attention to detail, and the ability to communicate effectively with multidisciplinary teams are crucial soft skills. These competencies ensure the accurate, timely, and compliant execution of complex bioanalytical studies critical to drug development and regulatory approval.

What are the typical challenges a bioanalytical study manager faces when coordinating multiple studies simultaneously?

Bioanalytical Study Managers often juggle several studies at once, which requires strong organizational and communication skills. Common challenges include aligning timelines across cross-functional teams, ensuring strict adherence to regulatory guidelines, and effectively managing unexpected changes in project scope or resources. Successfully navigating these challenges involves proactive planning, clear documentation, and regular status updates with both laboratory staff and external partners. This role is highly collaborative, and building strong working relationships with scientists, project managers, and clients is essential for meeting study milestones.

Associate Clinical Study Manager (San Antonio, Tx)

San Antonio, TX • On-site

Worldwide Clinical Trials
Scientific Research and Development Services • 10K+ employees
Learn more about Worldwide Clinical Trialsexternal

$19.95 - $39.66/hr

Full-time

Re-posted yesterday

Key responsibilities

  • Coordinate study monitoring visits and ensure follow-up action items are completed in a timely manner.

  • Work collaboratively with clinic departments to address queries and manage study documentation.

  • Facilitate shipment of samples and ensure staff training is documented according to study protocols and regulations.

Job description

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.

What you will bring to the role

  • 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.

Your experience

  • Bachelor's Degree (Life Sciences or Health preferred) or 4 years clinical research experience Or Associates Degree with 2 years clinical research experience.

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):


United States of America - $19.95 - $39.66


The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide!For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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