Job type full-time
Not provided by employer
Full job description
Provide scientific support for all medical development activities involving the conduct of clinical studies, including: study feasibility, data management requirements, preparation of meeting materials and internal/external presentations, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports and study close-out activities, writing manuscripts (paper, abstracts, posters, etc.), and reviewing and summarizing relevant literature.
Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety and assist in communicating a clear overview of trial resultsThe role will report to a medical director and will collaborate with clinical pharmacology, clinical research and other functions as appropriate.
Work closely with medical directors, pharmacology, discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
Assist medical directors in creation of proposed concept sheets for clinical studies and may write protocols and informed consent documents through incorporation of input from both internal and external experts
Assist with the annual update of ib with input from toxicology, pharmacology, safety, regulatory
Drive and integrates clinical contribution to answering regulatory queries and other submissions related to studies
Monitor and review along with the medical monitor safety and efficacy data in ongoing studies; monitors gcp compliance with help of clinical operations and cro
Involved in high level data cleaning activities requiring clinical judgment involved in analysis of complex data for regulatory submissions, publications and design of studies and programs
Attend scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors
Work with investigative sites to answer protocol related questions, resolve study conduct and design issues
May present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
Minimum requirements: *
Bachelor`s degree in scientific/life sciences/clinical/nursing fieldAdvanced degree preferred.
5+ years of clinical drug development experience preferred
Prior hematology or oncology drug development experience a plus
Ability to work in a highly collaborative, matrix environment with the ability to manage through conflict resolution
Excellent written and oral communication skills
Strong analytical ability and detail oriented
*potentially open to remote work, but would prefer someone with the ability to come onsite.*
Job type: full-time
Posted 8 days ago