Biomarker Project Manager, I
AbbVieSouth san franciscoUpdate time: October 1,2021
Job Description
About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Manage the biomarker operations and logistics to align with clinical trial schedule Co-manage with lead biomarker scientist to support regular updates to cross-functional stakeholders for each trial Key contributor of relevant clinical study documents and associated systems (including trial blueprint/protocol, Informed consent forms, eCRFs, CSRs, etc.) Respond to EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining AbbVie biomarker standard language and study timelines Support biomarker vendor selection and research scope; managing contract execution and vendor oversight in compliance with AbbVie's processes, procedures and applicable regulations Contributes to the accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, logistics and shipping as needed Contributes to generation of study related training for the study team, study sites and vendors for each trial Coordinate sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases Responsible for samples management, storage, and/or destruction per requirements Deposit biomarker related documents to the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’ Learn to identify and resolve and/or escalate study-related issues Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines Develop into a subject matter expert (SME) and resource for one or more processes in BPM Participate in process improvement initiatives for improving efficiency as needed, as well as instructions and manuals for internal training purposes Contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels Balance multiple priorities in a fast-paced, team-based environment and work independently when needed Qualifications Master’s Degree with 4+ years project management, oncology and/or clinical trial experience Bachelor’s Degree with 6+ years of project management, oncology and/or clinical trial experience Expertise in MS Office applications including Excel, Word and PowerPoint Excellent oral and written communication skills in English Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills PMP certification a plus Minimum 2+ years direct clinical trial management experience, with exposure spanning initiation through study completion Scientific background and knowledge of oncology Ability to work with minor supervision Experience holding meetings by teleconference and working with colleagues remotely Effectively work in a cross-functional team environment and ability to interact with various levels within the organization as well as vendors Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
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