Biomarker Operations Project Manager (East Coast)

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Exceptional Opportunity: Biomarker Operations Project Manager at Parexel! Are you ready to take your biomarker operations expertise to the next level? If so, we are seeking a talented and ambitious Biomarker Operations Project Manager to join our world-class team and work closely with a large global client in advancing their cutting-edge clinical research through innovative biomarker strategies. As a Biomarker Operations Project Manager, you will support the operational set-up and management of biomarker specimens collected in global clinical trials. As a key contributor to the clinical biomarker strategy, you will be accountable for working effectively with cross-functional teams on planning, implementation, and execution of clinical biomarker specimen collection, testing and data delivery activities. Description of Role & Responsibilities: Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using strategies to ensure efficient trial execution Act as the operational partner to the biomarker scientific leads to aid in implementing strategies that drive clinical trial biomarker programs forward Participate as a co-author for drafting relevant biomarker sections of clinical study protocols Work closely with scientists to manage specimen collection, handling, shipping, and storage guidelines that align with biomarker plans and clinical study protocols Accountable for providing biomarker vendor assay statements of work and data transfer specifications to the clinical teams Work with data management to effectively transfer biomarker data to clinical data repository from external biomarker vendors Work with clinical teams and/or central labs to design sample collection kits, laboratory manuals, and specimen logistics for shipments to third party vendors Maintain and grow effective partnerships with external biomarker vendors and internal client teams Coordinate sample and assay logistics and serve as a key point of contact with vendors/collaborators for timeline tracking, issue resolution and risk mitigation Skills and Experience: Basic knowledge of clinical trial set-up and execution is required Scientific, medical and/or safety writing and reporting is required (experience in at least one of these areas) Drug discovery and/or development experience is preferred Understanding of basic lab techniques in the life sciences is preferred Ability to understand conflicting needs of key stakeholders Strong issue identification and resolution skills Well-organized and methodical approach to problem solving Ability to collaborate effectively with a cross-functional team Experience in working with third party vendors preferred Knowledge of GCP, ICH guidelines, and regulatory requirements Ability to collaborate effectively with a team Must be self-motivated, and independent with self-awareness to know when to ask questions Ability to manage complex projects under accelerated timelines Can independently prioritize work based on project needs and requirements Able to learn quickly and be proficient in applicable tools and databases used to support the activities required for this role Experience with MS Office Suite Excellent communication skills, both written and oral Educational Requirements: BA/BS with a science background required This is a remote position. Candidates located in the EST are preferred, however, consideration will be given to exceptional candidates in the CST who have the ability to work East Coast hours #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.