Manager, Clinical Research

SGS•Richardson, TX

About The Position

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. Identification and hiring of appropriate clinic staff, preparation of annual reviews and handing of performance issues, if any, with the assistance of the Human Resources Manager Oversees the training, mentoring and career development of all clinic staff Understands requirements for all studies and communicates to all personnel/departments involved in each study Works closely with recruiting manager to ensure study panelists meet protocol requirements Assists in clinic staff scheduling to ensure all studies are staffed appropriately Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures Oversees the clinic conduct of each study and/or delegates supervisors to oversee when unavailable Ensures that supplies and equipment needed from clients are available for studies as necessary Identifies and provides solutions to clinical trial issues and/or risks Ensures inventory of internal supplies needed for studies is at a level to support current and upcoming studies Contributes to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents Identifies, develops, and reviews company policies and procedures Works closely with sponsor’s and monitors during site qualification, monitoring, and auditing visits Identifies areas of improvement, especially related to quality and efficiency, and implements solutions Understanding of the site's P&L and how clincal operations can impact the P&L Manages staff and resources while considering the P&L for the site

Requirements

Bachelor's Degree, preferably in science
5+ years in Clinical Research
Minimum of 4 years of Supervisory/Leader experience
Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
Ability to develop collaborative relationships with internal and external stakeholders.
Strong decision-making/analytical skills
Proficiency with Microsoft Office applications
Knowledge of GCP/CLP guidelines and Federal Regulations related to the conduct of clinical trials, NIH training and CCRC/CCRA certification a strong plus

Responsibilities

Identification and hiring of appropriate clinic staff, preparation of annual reviews and handing of performance issues, if any, with the assistance of the Human Resources Manager
Oversees the training, mentoring and career development of all clinic staff
Understands requirements for all studies and communicates to all personnel/departments involved in each study
Works closely with recruiting manager to ensure study panelists meet protocol requirements
Assists in clinic staff scheduling to ensure all studies are staffed appropriately
Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures
Oversees the clinic conduct of each study and/or delegates supervisors to oversee when unavailable
Ensures that supplies and equipment needed from clients are available for studies as necessary
Identifies and provides solutions to clinical trial issues and/or risks
Ensures inventory of internal supplies needed for studies is at a level to support current and upcoming studies
Contributes to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
Identifies, develops, and reviews company policies and procedures
Works closely with sponsor’s and monitors during site qualification, monitoring, and auditing visits
Identifies areas of improvement, especially related to quality and efficiency, and implements solutions
Understanding of the site's P&L and how clincal operations can impact the P&L
Manages staff and resources while considering the P&L for the site