Duration: 12+ months contract
Digital Science Team is an ambitious team with a unique blend of medical knowledge, digital technologies, regulatory and data science expertise that seeks to empower clinical development, doctors, and patients with digital health tools to objectively measure aspects of diseases, detect treatment benefits, unlock new value for our portfolio, and drive the future of the business. The Digital Science Team drives the quality and validation of digital health tools and supports the development of digital endpoints, advance medicine development, and bring digital strategies to life for Client and patients.
Responsibilities:
• Support Digital Strategy Lead in the development of digital strategy and Client endpoint and provide input in the patient insight research, technologies evaluation, usability testing, vendor qualification, and validation of digital health tools for use in clinical trials
• Collaborate with medical colleagues and Therapeutic Areas to implement digital strategies, aligned to asset strategy that generates high-quality evidence suitable to support decision making, label enhancement, or market access
• Support analytical validation studies of digital tools, adhere to PFDD, DDTQ, CTTI guidances as well as other relevant federal and international regulations, including GCP, ICH Guidelines, Client Standard Operating Procedures (SOPs), and to functional quality standards. Stay abreast of new and evolving regulations, guidelines and policies related to digital health and clinical development
• Work with internal and external partners, including vendors, BTS, procurement, regulatory, legal, and QA to enable the qualification of selected digital health tools
• manage multiple digital projects with people and project management skills, e.g. create project plans, trackers, monitor scope, budget, timeline, and report milestones/progress
• Identify business needs and support the creation of reports, SOPs, publications
Qualifications:
• Bachelor's, preferred graduated training in life science, clinical, public health or related field with 1-3 years (BS) of relevant experience in the pharmaceutical, healthcare, consulting, or medical device industry
• Solid understanding of the drug development process and ICH, GCP requirements, with experience in clinical development, data management, health outcome research, or regulatory science
• Proficient in project management tools, e.g. Microsoft project, Planisware, smartsheet
• Methodical, detail-oriented with the ability to organize and manage multiple projects, as well as collaborate and influence cross-functionally
• Demonstrate critical thinking, value-evidence mindset, and problem-solving skills
• Strong communication skills in verbal and writing with ability in . Expertise in slide creation would be a plus
• Self-starter, ability to navigate a highly complex and matrixed organization
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.