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Other Locations:Switzerland- Boudry
DescriptionCelgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.****This is a field based position and can be located anywhere in Europe (with occasional travel to our International HQ in Boudry, near Neuchatel, Switzerland).****Here is an opportunity to join Celgene's Biospecimen Operations (BSO) group, who focus on management of biospecimens for Celgene-sponsored clinical trials (and commercially acquired biospecimens governed by Material and Data Transfer Agreements) The Consent Specialist will focus on patient informed consent and the management of consent parameters that govern the retention period, use and re-use of biospecimens collected during the course of a clinical trial. In addition, the consent specialist will be responsible for reviewing and interpreting contracts for scope of allowable use for commercially acquired biospecimens.This role will support the BSO Biorepository Associate Director as a subject-matter expert in patient informed consent and regulatory topics around biospecimens from the perspective of Institutional Review Boards (IRBs), Ethics Committees (ECs), International Health Authorities and country laws/regulations. The Consent Specialist will be expected to optimize processes around interpreting and documenting clinical trial biospecimen consent parameters from study, country and site-specific consent templates for a specific study and upload these parameters into a technology tool.The Consent Specialist will act as a mentor to peers and is expected to assist them with consent related IRB/EC queries as well as provide training to help develop a group of consent experts within BSO.Responsibilities will include, but are not limited to, the following:The Consent Specialist in BSO is expected to review consent documents and interpret consent allowable uses and retention periods in order to maintain adherence to the collection, retention and utilization of biospecimens in line with the informed consent signed by the subject. In doing so, the incumbent is expected to stay current on the broader regulatory landscape related to biospecimens. Apply subject matter expertise to the review of informed consent documents, including study, regional, country, and site-level documents, and summarize information regarding use and retention
Guide CROs and clinical teams on the proper use of protocol and informed consent template materials for the collection and use of biospecimens in Celgene clinical studies
Provide support for resolving IRB/IEC queries related to biospecimens for Celgene clinical studies
Review, interpret and track allowable uses in contracts for commercially acquired biospecimens.
Assist with the development and updating of policies, standard operating procedures (SOPs) and working procedures (WPs) related to consent oversight. Be able to identify complex biospecimen-related consent permissions. Play a key role in planning and designing clinical trial and biospecimen operations support internally and externally.
Utilize software tools to track consent parameters, verify and document consent prior to release for utilization, and ensure compliant utilization of biospecimens by following written procedures
Skills/Knowledge Required:Bachelors Degree in a life sciences or healthcare related field with 6+ years related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
OR Masters Degree in a life sciences or healthcare related field and 5+ years related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
The incumbent should have proficient skills in each of the following areas and have demonstrated application in the context of clinical trials and biospecimen management.Clinical Trials: Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials.
Biobanking: Understanding of global biobanking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general biospecimen transportation requirements.
Informed Consent: Subject-matter expertise in patient informed consent and regulatory topics around bio specimens from the perspective of Institutional Review Boards (IRBs), Ethics Committees (ECs), International Health Authorities and country laws/regulations
Drug Development: Proficient understanding of the drug development process.
Professional inter-personal skills and excellent oral/written communication. Experienced in presenting to internal and external audiences.
Basic leadership skills in conflict management, facilitation and negotiation.
Proficient computer skills in Microsoft Office.
Experience with consent tracking databases preferred.
Up to 10% travel to conferences to stay up to date on global regulations on biospecimens.