Careers
Esperion is a small company doing big science. Ours is an exciting and fast-paced business which makes it both very demanding and very rewarding. Top-notch colleagues, innovative and important work, and unfailing commitment and pride in what we do make Esperion a great place to work.
How'd we get our name?
What drives our work? Our core values:
The Esperion team is driven by personal pride in what we do. Our colleagues are undaunted by seemingly insurmountable obstacles, confident in their ability to rise to the challenge. They bring professionalism and integrity to their work and we're lucky to have them. Together, we're exploring, creating, and building upon our collective understanding of basic science to develop novel therapies for treating cardiovascular and metabolic diseases.
Esperion is a place where competing ideas thrive, where conflict is about developing the best solution. Our processes are collaborative and iterative. We recognize that putting our multiple and diverse heads together creates better results. We push each other and support each other in our quest to develop new pathways to better health.
Our team is comprised of exceptional and experienced scientists, committed to scientific excellence in everything they do. This means we apply rigorous scientific methods to design experiments, collect data, and analyze the results. It means we think critically and analytically, always seeking to learn from our efforts. And it means we have the courage and expertise to challenge conventional thinking and move innovative technologies to the forefront of medicine. We seek to understand the basic science, find its therapeutic applications to treat human disease, and make a difference in patients' lives.
Clinical Trial Manager
Description
The Clinical Trial Manager will provide day to day management of operations of clinical studies including study
start-up, conduct and close-out activities. These activities may be coordinated in conjunction with one or more CROs.
The Clinical Trial Manager will be located at the Esperion office in Plymouth, Michigan. Some travel may be required.
Responsibilities
- Day to day interactions with CROs, vendors, consultants and clinical sites
- Develop Request for Proposal (RFPs) and scope of work documents, coordinate RFP review in collaboration with the clinical study team
- Oversee system for tracking study progress; monitor study progress to ensure adherence to timelines, SOPs, and applicable regulations
- Identify tasks required for successful study execution and direct team members to effectively accomplish objectives
- Oversee the projection, ordering and tracking of study medication
- Manage high level study issues that require cross functional and/or management input
- Coordinate the development of study documents including but not limited to Study Operations Manuals, Pharmacy Binders and CRFs
- Oversee collection of required regulatory documentation from clinical sites
- Review monitoring reports and manage the monitoring of clinical studies
- Contribute to the development and maintenance of Clinical department operations including the development and review of SOPs
- Coordinate the evaluation, selection and contract completion of new investigators and vendors
- Develop study timelines and budgets in collaboration with the clinical study team
- Direct the planning of site initiation visits, Investigator Meetings and other study meetings
- Review and provide input into key clinical documents including the protocol, CRFs, monitoring plan, data management plan
- Ensure trial adherence to ICH/GCP/local regulations
Requirements
- This position is office based and may require some travel
- Minimum 5 years of relevant experience at a CRO or pharmaceutical company
- Working knowledge of GCP, ICH guidelines, and FDA regulations
- Therapeutic expertise in CV and metabolic diseases is desirable
- Proficient computer skills across multiple applications with an aptitude for clinical trial software
- Excellent oral and written communication skills and strong organizational abilities
- Experience is required developing trial plans including site monitoring strategies, trial budgets, site selection, and clinical supplies management; experience with IVRS and EDS systems is desirable
- Ability to collaborate effectively with cross-functional team members and make necessary decisions
- Bachelor's degree in a scientific or health related discipline
Applicants should send their resume and cover letter to hr@esperion.com.
Esperion is an equal opportunity employer. For more information, please contact us.