GCS/IRT Oversight Manager

Summarized Purpose:

Manages full supply chain and interactive response technology oversight for high complex global clinical trials. Ensures project/study activities are in compliance with company and client requirements. Mentors, trains and provides on-going support to junior team members. May act as main contact and escalation point for assigned clients. Provides consultation services to clients and may develop and update client-specific manuals. Builds and maintains client relationships.

Essential Functions: Develops study specific plans for each assigned project. Meets with internal teams to coordinate efforts, provide recommendations and risks, and update project reports/spreadsheets. May i ntegrate all clinical supplies activities into the supply chain to support project logistic strategy and compliance with GxP requirements. May develop client-specific interactive response technology standards and proactively obtain feedback regarding interactive response technology systems. Participates in ongoing training on new regulations. Participates in asepcts of the bidding process. Represents the department internally and externally at meetings, strategic projects, audits, bid defense meetings and initiatives as per the business requirements. Participates in or leads process improvement initiatives. Actively supports the roll-out of new processes within the department. Maintains and uses existing tools while continously looking for improvement opportunities. Consults the client on the best strategy for management of the clinical trial. Builds strong internal and external network. May act as a back-up for the functional projectmanager.

Summarized Purpose:

Manages full supply chain and interactive response technology oversight for high complex global clinical trials. Ensures project/study activities are in compliance with company and client requirements. Mentors, trains and provides on-going support to junior team members. May act as main contact and escalation point for assigned clients. Provides consultation services to clients and may develop and update client-specific manuals. Builds and maintains client relationships.

Essential Functions: Develops study specific plans for each assigned project. Meets with internal teams to coordinate efforts, provide recommendations and risks, and update project reports/spreadsheets. May i ntegrate all clinical supplies activities into the supply chain to support project logistic strategy and compliance with GxP requirements. May develop client-specific interactive response technology standards and proactively obtain feedback regarding interactive response technology systems. Participates in ongoing training on new regulations. Participates in asepcts of the bidding process. Represents the department internally and externally at meetings, strategic projects, audits, bid defense meetings and initiatives as per the business requirements. Participates in or leads process improvement initiatives. Actively supports the roll-out of new processes within the department. Maintains and uses existing tools while continously looking for improvement opportunities. Consults the client on the best strategy for management of the clinical trial. Builds strong internal and external network. May act as a back-up for the functional projectmanager.

Education and Experience: 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 8 years).

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.

Knowledge, Skills and Abilities: Excellent English and communication skills both written and verbal Exceptional interpersonal, planning, organizational, problem solving, sense of urgency and decision making skills Demonstrated leadership and team building skills Strong working knowledge of Microsoft Office suite and various analytics and visualization software Sharp focus on customers and attention to detail Ability to work in team environment, as well as work completely independent Comprehensive understanding of clinical supply operation Comprehensive understanding of IRT concepts and application to clinical trials including a strong understanding of randomization and/or material management methodologies Comprehensive understanding of software development process Exceptional client building and 3rd party relationship management Excellent ability to provide customer service with the highest standards of quality and excellence Superb skill in bid preparation and bid defense Strong presentation skills and proven ability to represent the department

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.)

Education and Experience: 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 8 years).

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.

Knowledge, Skills and Abilities: Excellent English and communication skills both written and verbal Exceptional interpersonal, planning, organizational, problem solving, sense of urgency and decision making skills Demonstrated leadership and team building skills Strong working knowledge of Microsoft Office suite and various analytics and visualization software Sharp focus on customers and attention to detail Ability to work in team environment, as well as work completely independent Comprehensive understanding of clinical supply operation Comprehensive understanding of IRT concepts and application to clinical trials including a strong understanding of randomization and/or material management methodologies Comprehensive understanding of software development process Exceptional client building and 3rd party relationship management Excellent ability to provide customer service with the highest standards of quality and excellence Superb skill in bid preparation and bid defense Strong presentation skills and proven ability to represent the department

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.)