As part of a team working on AVEO global oncology clinical trials, the person will focus on Clinical Pharmacology studies within the Clinical organization.
Responsibilities include but are not limited to the following:
- Assisting with developing study protocols, Informed Consents and Investigator Brochures.
- Assisting in the preparation of documents for Regulatory activities and submissions.
- Participating in the identification, selection and qualification of clinical investigative sites, as required.
- Biobank Sample Tracking and management of Biorepository vendor
- Partner with Clinical Operations, Biostatistics, Medical, Regulatory, Preclinical and Legal staff assigned to program to ensure execution is consistent with intent.
- Participate in the preparation of clinical study reports and annual reports.
- Participate in CRF development and study data reviews
- Identifying outsourcing vendors, setting up meetings, presentations and request proposals (RFPs);
- Working with Clinical Operations on the scope of responsibilities with outsourcing vendors;
- Work closely with the preclinical and clinical teams on the logistics of incorporating specific biomarker and other project specific laboratory assays into protocols.
- Assisting in the management of external vendors and CROs that are associated with pharmacokinetics, pharmacogenomic and biomarker data
- Tracking of samples and sample analysis throughout the various stages of the study;
- Assisting with preparation and presentation at investigator meetings and/or sites as required;
- Developing study/clinical site specific guidelines and tools as necessary;
- Presentation at internal meetings as necessary
- Participating in Investigator Meetings and Advisory Boards as necessary;
- Assist in preparation of abstracts, manuscripts, posters and slide sets for publication.
- Assist in analysis of data as required.
- BS/BA degree in life sciences
- 5+ yrs of industry clinical research experience (biotech/ pharma/ CRO);
- Experience with writing study protocols
- Experience and interest in Clinical Pharmacology a plus
- Understanding of ICH, GCP and relevant regulatory requirements is highly desirable;
- Vendor management experience a plus
- Strong attention to detail;
- Solid time management skills;
- Ability to multi-task, work independently, and travel up to 15% of time;
- Excellent verbal and written communication skills;
- Strong inter-personal skills;
- Excellent computer skills, specifically hands-on experience with Word, Power Point and Excel.
Aveo Oncology - 17 months ago