Clinical Project Manager I
Clinical Project Manager I
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Support Digital Strategy Lead in the development of digital strategy and novel 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 guidance 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.
Requirements:
- Bachelors 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.
- 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.
- Expertise in slide creation would be a plus.
- Self-starter ability to navigate a highly complex and matrixed organization.
Employment Type
Full-time
