Job title: Associate Manager, Imaging – Oncology
Job description: At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world’s most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The incumbent will act as the study team Imaging functional representative for assigned studies. Responsibilities include acting as the functional representative for all Imaging associated study team activities such as: tumor assessment CRF development, site tumor assessment data review, and cross functional oversight of imaging core laboratories working on Eisai Oncology clinical trials. Since many of the Oncology study primary endpoints are image based, it is critical that the acquisition and analysis of these endpoints be closely monitored to ensure quality data for Eisai.
- Imaging function review and approval of imaging core laboratory study startup documents (transmittal forms, site imaging manuals, communication plans)
- Contribute to reconciliation of scans review (scans received by imaging core labs relative to CRF data)
- Review of data transfer specifications and clinical data transfer plans from/to imaging core labs in conjunction with Clinical Data Management
- Monitor and interpret imaging vendor reports (e.g. issues report, missing scans) for discussion during internal clinical study team meetings, teleconferences with CROs and imaging core laboratories, to facilitate resolution by Clinical Operations and CROs
- Review tumor assessment sections of patient profiles from site CRF data and provide feedback to Clinical Data Management for site queries
- Proactively develop, assess, and analyze cross functional action plans related to imaging when needed in support of study team objectives
- Contribute to the creation of and adherence to study team timelines outlining imaging associated milestones
- Identify cross study vendor specific issues and escalate to imaging management
- Contribute to imaging functional group general activities including process improvement initiatives
- Bachelor’s Degree required in related scientific discipline.
- Three (3) years of experienced including working on clinical trials with imaging aspects required.
- Scientific background with understanding of clinical development and drug development process together with a broad understanding of clinical trials using medical imaging including the roles of clinical operations and data management.
- Strong verbal, written and interpersonal communication skills, especially relationship management with ability to give/receive feedback and build consensus.
- Experience with operational aspects of clinical trials.
- Familiarity with oncology image-based tumor response criteria such as RECIST 1.1, RANO, irRECIST and iRECIST criteria.
- Experience in oversight and management of imaging CROs to ensure successful conduct of the imaging aspects of clinical trials ensuring data integrity and quality.
- Ability to work semi-autonomously with strong organizational prioritization and analytical skills. Independent decisions may be made regarding approval of study startup documents (such as transmittal forms), content of imaging core laboratory presentations, and imaging manuals.
- Imaging Core Laboratory experience (working with or for a core lab) strongly preferred.
- 5-10% travel expected.
- Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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Location: Nutley, NJ
Job date: Sat, 09 Jul 2022 06:44:13 GMT
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