Team Lead, Investigator Site Services

Thermo Fisher Scientific•Covington, KY

3d•Hybrid

About The Position

The Team Lead Site Services ensures efficient and effective operations of the department and is responsible for quality within the section. Participates in the daily operations of the departments supported or where needed and follows up on complaints/issues until resolution. Provides training for new personnel or when new processes are implemented. Follows up on training documentation of the team. Attends study protocol meetings and educates staff on issues requiring attention. Creates work schedule and holiday planning for the team. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. Discover Impactful Work: Provides support to investigator sites, monitors, department, business unit or function through communication of information, training sites and documentation of services pertaining to clinical trials. Supports the overall performance, education and training of the sites on a study level to ensure the execution of protocols are completed accurately and on time. Uses the tools provided to answer all questions, takes orders and ensure clean data at the earliest point in time. A day in the Life: Directs and participates in all aspect of daily operations of the department. Manages the Associate Site Services Assistance and Logistics Coordinators including performance maintained. Mains and Oversees Manufacture List; Supply Orders; Courier Contact Sheets; Backorders; Special Account Set Up. Provides training to new staff members and when new processes are implemented. Evaluates Performance and identifies and corrects performance problems. Point of escalation for calls related to supplies and logistical issues and escalates to management/appropriate department to ensure satisfaction of internal and external customers. Coordinates and resolves issues/concerns during the study set up process with the Site Services Logistics Coordinators and Associate Site Services Assistance. Obtains and Maintains the Key Performance Indicators with the kit vendors. Assist Management with training; quality compliance; SOP reviews and updates. Creates monthly task schedule for the GSS ISS team. Accurately reviews and modifies SOP’s, assists with CQE’s when necessary. Accurately reviews and provides information on Audit findings. Provides GSS overviews/shadowing for other PPD department team members. Assists in interviewing processes for GSS members. Also, for other PPD departments if necessary. Acts as a backup to the Supervisor and/or Senior Manager

Requirements

Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years)
1+ year of leadership responsibility
Knowledge of Good Clinical Practices
Strong attention to detail
Strong organizational skills
Accurate data entry skills
Proficient computer skills including Microsoft Office
Effective negotiation and problem resolution skills
Good verbal communication skills
Superior analytical, interpersonal and time management skills
Critical thinking and problem solving skills to support quality decision making
Ability to work in a collaborative team environment

Nice To Haves

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Responsibilities

Ensures efficient and effective operations of the department and is responsible for quality within the section.
Participates in the daily operations of the departments supported or where needed and follows up on complaints/issues until resolution.
Provides training for new personnel or when new processes are implemented.
Follows up on training documentation of the team.
Attends study protocol meetings and educates staff on issues requiring attention.
Creates work schedule and holiday planning for the team.
Provides support to investigator sites, monitors, department, business unit or function through communication of information, training sites and documentation of services pertaining to clinical trials.
Supports the overall performance, education and training of the sites on a study level to ensure the execution of protocols are completed accurately and on time.
Uses the tools provided to answer all questions, takes orders and ensure clean data at the earliest point in time.
Directs and participates in all aspect of daily operations of the department.
Manages the Associate Site Services Assistance and Logistics Coordinators including performance maintained.
Maintains and Oversees Manufacture List; Supply Orders; Courier Contact Sheets; Backorders; Special Account Set Up.
Provides training to new staff members and when new processes are implemented.
Evaluates Performance and identifies and corrects performance problems.
Point of escalation for calls related to supplies and logistical issues and escalates to management/appropriate department to ensure satisfaction of internal and external customers.
Coordinates and resolves issues/concerns during the study set up process with the Site Services Logistics Coordinators and Associate Site Services Assistance.
Obtains and Maintains the Key Performance Indicators with the kit vendors.
Assist Management with training; quality compliance; SOP reviews and updates.
Creates monthly task schedule for the GSS ISS team.
Accurately reviews and modifies SOP’s, assists with CQE’s when necessary.
Accurately reviews and provides information on Audit findings.
Provides GSS overviews/shadowing for other PPD department team members.
Assists in interviewing processes for GSS members. Also, for other PPD departments if necessary.
Acts as a backup to the Supervisor and/or Senior Manager