CDM Principal Optimization Specialist

Remote North America

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.

Our Clinical Data Management team oversees all data collected in a clinical trial. This work spans the design and build of the EDC database, ingestion of all digital and vendor data sources, comprehensive data review and validation with a focus on high quality delivery of clinical trial data. We work closely with our project teams and customers across all therapeutic areas incorporating innovative technology and best practices to help our customers deliver life-changing therapies.

A day in the Life:

• Provides technical leadership and supports the Clinical Data Management (CDM) business to refine and automate business processes. Is technical business owner for implementation, maintenance, enhancements for CDM tools. Supports CDM technical strategy by leading technical evaluation of proposed tools and evolution of CDM future programming requirements. Gathers, analyzes and documents user requirements for proposed CDM initiatives to ensure beneficial return on investment. Supports CDM in Decentralized Technology (DCT) trials by understanding and documenting requirements of CDM in set-up and support of DCT technology and in the process for integration and/or data transfers from the DCT vendor. Supports CDM in development and implementation of AI/ML strategy. Liaises with IT and other critical functions to ensure requirements are appropriately aligned when appropriate. Document business requirements for new tools or programs and define scope with CDM leadership team. Lead internal understanding of external vendors to drive right time data acquisition. Collaborate with internal functions across PPD® clinical research portfolio to design and build value into platform offering and support of internal organization initiatives.
• Provides technical leadership over assigned CDM tools. Effectively works with CDM and multi-functional teams to provide end user support. Develops and maintains tool guidance documents. Works with the vendor to solve and identify vital improvements/bug fixes.
• When new technology is required, solicits and documents requirements for technology solution, analyzes those requirements and works with department leadership on next steps. Ensures that requirements are accurately translated into design specification for systems and/or reports as applicable.
• Works independently and with CDM leadership to define, streamline and automate business process.
• Provides support in relevant SOP/WPD development and modification.
• Works with DCT counterparts within the PPD Digital team to understand technology applications, identify how CDM interacts with the technology, develops RACI around CDM programming engagement and hand-over points specific to each DCT technology. Supports implementation of DCT into the project and provides guidance as needed during the maintenance phase of the study. Drives solutions around DCT integration and import/transfer requirements.
• Works with CDM Programming leadership to tackle sophisticated support issues and analyzes root cause for enhancement opportunity and identifies workarounds or works with IT to design solutions.
• When new technology is to be used, investigates the operational requirements of the tool and trains appropriate roles within CDM. Supports multi-functional training as necessary.
• May serve in a study or initiative lead capacity as the need arises.
• Attends client meetings when needed to support CDM operational teams. May need to attend audits (client and regulatory) as necessary.
• Proactively seeks information across industry on the latest developments in relevant technologies. Shares knowledge with team members.
• Performs other duties as assigned.

Education / 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/or Abilities:

• In depth knowledge of industry processes including applicable SOPs, ICH GCP, industry data collection tools and applicable regulations
• Knowledge of programming languages associated with AI, EDC, DCT and data acquisition and reporting including SAS, C#, R, Python.
• Strong knowledge of clinical research, core clinical data managers. Understand the end user experience to ensure technology meets the operational need.
• Knowledge of workflow/process automation
• concepts and tools
• Good business understanding of clinical data management systems, DCT and clinical systems
• Solid focus on future direction of the clinical research industry and ability to align the right technology and process.
• Client-focused approach with strong interpersonal skills
• Strong written and verbal communication skills
• Robust problem solving and analytical skills
• Strong planning and organizational skills
• Highly proficient in Microsoft Office applications
• Ability to multi-task with solid attention to detail
• Ability to lead and mentor others within a project team
• Demonstrable ability to work within a team or independently as required

Thermo Fisher Scientific 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.)

The salary range estimated for this position is $96,300-160,000. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer. 

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:

• A choice of national medical and dental plans, and a national vision plan.
• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA).
• Tax-advantaged savings and spending accounts and commuter benefits.
• Employee assistance program.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy.
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan.

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.

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.

Accessibility/Disability Access

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