IRT Oversight Mgr

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
From purchasing to global inventory management and from distribution to destruction, PPD’s integrated global clinical supplies (GCS) services are designed to increase speed and efficiency, without sacrificing the quality you expect.
The IRT Oversight Mgr handles the full interactive response technology oversight for global clinical trials. You will ensure project/study activities are in compliance with company and sponsor requirements. Meet with internal teams to coordinate efforts, provide recommendations and risks, and update project reports/spreadsheets. Serve as an escalation contact with clinical project management teams and sponsors. Develop bidding strategy for each assigned bid. Present and explain capabilities to sponsors and aid in business acquisition. Represent the department for internal, sponsor and regulatory audits as needed. Provide consultation services to sponsors and develop and update sponsor-specific manuals/standards. Build and maintain sponsor relationships.

Key Responsibilities

• Develops study specific plans for each assigned project.
• Meets with internal teams to coordinate efforts, provide recommendations and risks, and update project reports/spreadsheets.
• Participates in ongoing training on new regulations.
• Participates in aspects of the bidding process.
• Represents the department internally and externally at meetings, strategic projects, 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 continuously 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 manager.

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
• 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
• 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

Working Environment:
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.
This position is open for LATAM on fully remote status.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone

• Develops study specific plans for each assigned project.
• Meets with internal teams to coordinate efforts, provide recommendations and risks, and update project reports/spreadsheets.
• Participates in ongoing training on new regulations.
• Participates in aspects of the bidding process.
• Represents the department internally and externally at meetings, strategic projects, 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 continuously 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 manager