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SGS · 12 hours ago

Manager, Clinical Research

1801 N Glenville Dr, Richardson, TX 75081, USA

Full-time

Onsite

Mid, Senior Level

5+ years exp

SGS is the world's leading testing, inspection, and certification company, recognized for sustainability and quality. They are seeking a Manager for Clinical Research who will oversee clinic staff, ensure studies adhere to protocols, and manage resources while maintaining quality and efficiency in clinical trials.

OutsourcingSkill AssessmentTest and Measurement

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 clinical operations can impact the P&L

Manages staff and resources while considering the P&L for the site

Qualification

Clinical ResearchSupervisory ExperienceGCP/CLP KnowledgeMicrosoft OfficeProject ManagementAnalytical SkillsStakeholder Collaboration

Required

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