Research Operations
3 weeks ago
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
Summary of Role
Support the Investigator Sponsored Trial program across the Lantheus Medical Imaging portfolio for all Lantheus assets, including all processes related to multiple functional areas.
Essential Functions
- Provide operational support to the Global Investigator Sponsored Trial program by organizing and recording required procedural documents, email communications and study information in accordance with GMA SOPs.
- Ensures IST/Clinical Grant study files meet GCP requirements, regulatory and financial requirements to accurately reflect the content and status of all IST's.
- Interact as needed with investigators, applicants and site staff as needed to collect necessary proposal forms, provide status updates and re-direct to the appropriate GMA contacts.
- Support the IST agreement (contract) process for all IST's, in collaboration with medical, legal, and regulatory functions.
- Lead all operational tasks & document completion related to IST program payments processes in collaboration with Accounts Payable & Finance teams.
- Oversee the document management of all IST legal agreement negotiations, track redline status, and update records appropriately.
- Perform all document routing requests and version controls on Clinical Trial Agreements & Non-Disclosure Agreements pertaining to the IST program.
- Support activities to drive adherence to timelines, program objectives and monitoring plans. Accountable for accuracy and timeliness of information in all databases and tracking systems.
- Develops and maintains knowledge of regulatory and operational aspects of the management of clinical trials in all countries where ISTs are located in collaboration with GMA IST research team.
- Oversee the financial tracking of all IST support, Purchase Order information, milestone progress and resource commitments on a regular basis.
- Helps Ensures accurate reporting on milestone progress, invoice accrual and provide yearly estimated budget forecasting to finance team on a regular basis.
- Recognizes and escalates to appropriate personnel significant issues relating to compliance, timelines or other issues that jeopardize business objectives.
- Actively demonstrates and promotes the Lantheus values of accountability, quality, efficiency, customer service, collaboration, and safety.
- Manages multiple competing responsibilities and adapt to continually shifting priorities and day to day demands.
Typical Minimum Skills and Experience and Education
- Bachelor's degree or equivalent in a scientific, business or health related field required.
- Knowledge of medical imaging field and diagnostics agents preferred.
- Project management training or one or more years of experience. Working knowledge of current ethical, GCP and regulatory guidelines.
- 2 + years of related professional industry experience involving grants contract management.
Other Requirements
- Excellent computer skills, including high proficiency with Microsoft Suite including Excel, Word, PowerPoint and MS Project as well as the Office 365 environment.
- Experience working with radiopharmaceuticals will be considered an asset but is not a requirement.
Core Values:
The ideal candidate will embody Lantheus core values:
- Let people be their best
- Respect one another and act as one
- Learn, adapt, and win
- Know someone's health is in our hands
- Own the solution and make it happen
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.
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