Clinical Research Study Manager

DM Clinical Research•Tomball, TX

About The Position

A Study Manager I ensures that quality research is conducted at assigned investigative sites in accordance with sponsor protocols, FDA Regulations, and ICH/GCP guidelines. The role manages clinical trials from FPFV through study closeout, maintaining adherence to study protocols and manuals, study documents, ICH-GCP guidelines, FDA Regulations, ALCOA-C standards, and organizational SOPs and guidance documents. The Study Manager trains site teams and supports the proper conduct and documentation of subject visits and other protocol-required procedures. The role promotes data quality, subject retention and compliance, timely study data reporting, safety reporting, and maintenance of essential clinical trial documents and Investigator Site Binders. It also supports site readiness and staff training, works with site and cross-functional teams, and helps meet sponsor enrollment goals. The position includes conducting patient consent discussions, explaining study protocols and procedures, and facilitating communication among patients, healthcare providers, and research staff.

Requirements

High school diploma or equivalent.
Minimum of 5 years of experience in clinical research (Senior Lead CRC).
Goal-driven while continuously maintaining quality.
Detail-oriented, proactive, and able to take initiative.
Strong written and communication skills.
Excellent customer service skills.
Proficient verbal and written English communication and comprehension skills.

Nice To Haves

Bachelor's degree.
Foreign medical graduate qualification.
Supervisory experience.
Experience across a wide range of clinical trial therapeutic areas.
Regulatory research experience.
ACRP or equivalent certification.
Proficient verbal and written English/Spanish communication and comprehension skills.

Responsibilities

Train site teams and support the adequate conduct of study subject visits and other protocol-required procedures, ensuring timely documentation.
Enforce ALCOA-C standards for relevant clinical trial documentation.
Ensure Adverse Events, Serious Adverse Events, and other relevant safety information are reported to appropriate authorities according to company guidelines, sponsor requirements, IRB requirements, and ICH-GCP guidelines.
Ensure data quality, subject retention and compliance, and timely, adequate study data reporting for assigned protocols at respective sites.
Manage clinical trials from FPFV through study closeout in accordance with study protocols, study manuals and documents, ICH-GCP guidelines, FDA Regulations, ALCOA-C standards, and organizational SOPs and guidance documents.
Complete sponsor-specified EDC, IVRS, and other relevant electronic systems training.
Prepare for sponsor and CRO visits for assigned protocols and follow up on action items in a timely and appropriate manner.
Maintain knowledge of essential clinical trial documents and maintain Investigator Site Binders for assigned protocols.
Create or review source documents for assigned protocols in a timely manner.
Work closely with the Associate Site Director or Site Director to achieve strategic site goals.
Assist the Associate Site Director or Site Director with staff training and other assigned tasks.
Strive to meet sponsor subject-enrollment goals for assigned protocols.
Work with cross-functional and site teams to ensure study-start readiness and completion of relevant staff training before FPFV, and support successful trial execution and completion.
Conduct patient consent discussions and ensure patients understand medical procedures, risks, benefits, and alternatives.
Explain study protocols clearly and ensure patients understand them before obtaining consent.
Facilitate effective communication among patients, healthcare providers, and research staff.