IRT Project Manager - Clinical Supplies

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

We have a vacancy for an IRT Manager in our Global Clinical Supplies Team.

The role is based in Bulgaria and can be fully office based (in Sofia), hybrid or fully remote in BG.

The role:

Serves as the IRT Project Manager during the study startup and maintenance phase in managing and supporting IRT system solutions within the constraints of scope and cost. Acts as the liaison between the study team and the selected IRT Vendor.  Works closely with the study team to ensure study design, build, and execution is performed effectively and with a high degree of quality. Measures and evaluates organizational processes and services to optimize business behaviours and performance. Typically coordinates multiple simple and/or moderately complex projects throughout the project life cycle.

A Day in the life:

• Serves as the primary IRT contact for sponsors and study team members during the life of the study including understanding the IRT system requirements and functionality and managing the IRT Vendor in all tasks related to the study.

• Partners with functional area leads to identify and evaluate fundamental issues on projects.

• Gathers information regarding potential or actual risks/issues and provides detailed information to management to ensure the risks/issues are surfaced and mitigated. Manages all IRT quality events that may arise for the study.

• Ensures the study is always audit ready.  Must attend and participate in any study audit that requires IRT attendance.

• Performs study specific informal testing, reviews study specific system support guidelines for accuracy and completeness.  Manages the UAT testing phase with all appropriate parties.

• Prepares, coordinates, and delivers meeting materials and communications per timeline milestones. Attends/facilitates meetings and communications with sponsors, vendors, and cross-functional team members.

• Manages the IRT budget for the life of the study.  Ensures accurate hours are included for various tasks.  Reviews and approves all vendor invoices.   Escalates any discrepancies or adjustments needed in the IRT budget.

Keys to success:

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 5+ 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:

• Strong attention to detail and problem solving skills

• Strong comprehensive oral presentation and written communication skills

• Strong proficiency in computer skills with knowledge of Microsoft Word, Excel, email software, various analytics and visualization software; and proficiency with primary software used by the company

• Fundamental understanding of relational database concepts and fundamental familiarity with data manipulation tools.

• Strong ability to adapt to changing priorities and to work as a member of a multi-disciplinary, global cross-functional team

• Basic knowledge of project management standards and practices

• Proven ability to develop and deliver services and solutions in a collaborative and cross-functional global environment, with an understanding of the user perspective

• Effective ability to query, compile, track and maintain data in systems supporting department programs and processes

• Solid familiarity of IRT system applications and concepts

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