BIOMARKER PROGRAM MANAGER III

Biomarker Program Manager III Location: North Chicago, Illinois Category: Scientific Salary: Apply for details Country: United States Employment: Contract Worksite: On-Site Apply For This Position Job Description Target PR Range: 50-60/hr Depending on experience Purpose: Within Precision Medicine (PMed), the Biomarker Program Management (BPM) team connects science and operations to manage biomarker research for multiple Phase 1-3 clinical trials. We are seeking an experienced and highly motivated individual who will employ operational and logistical strategies to ensure clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The successful candidate will have a proven track record of clinical trial experience and decision-making to achieve these objectives, including scientific expertise, strategic thinking, a patient-oriented mindset, team building and cross-functional collaboration. Responsibilities Manage biomarker operations and logistics to support the clinical trial schedule. Resolve or escalate biomarker study-related issues with PMed Lead or BPM Subject Matter Expert (SME).Responsible for relevant biomarker content in clinical study documents and associated systems (including clinical trial blueprint/protocol, informed consent forms, eCRFs, CSRs, etc). Ensure consistency across studies.Manage EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining biomarker standard language and study timelines. Responsible for generating study related training materials for the study team, study sites and vendors for each trial. Manage biomarker vendor selection and scope, managing contract execution and vendor oversight in compliance with procedures and applicable regulations. Responsible for the accurate forecasting and tracking of study costs associated with sample and results management, bioanalytical assays, logistics and shipping.Identify and resolve and/or escalate study-related issues and risks. Assist other team members to resolve risks.Lead efforts to improve PMed processes. Update BPM training materials to keep them current. Lead training for new PMed members for some sections of the Process Guides.Oversee sample analysis and data transfer tasks, ensuring timely sample shipments to vendors and/or storage sites and that the data are transferred to the correct databases. Oversee sample management, storage and/or destruction, per requirements. May work with or manage a Sample Operations Manager with responsibility for these tasks.Understand and ensure the biomarker strategy is implemented in trial documents and processes.Provide leadership and mentoring for team members; responsible for developing the expertise of team members. May manage contract or FTE, as needed. Set 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 set priorities for self per Department needs.Apply and adhere to ICH/GCP, biorepository procedures, biosample management best practices and ethical guidelines. Ensure appropriate documents are added to the Trial Master File. Qualifications Ph.D. Degree with 2+ years project management, clinical trial experience and biological science background, including biomarkers. Master’s Degree with 7+ years project management, clinical trial experience and biological science background, including biomarkers. Bachelor’s Degree with 10+ years of project management, clinical trial experience and biological science background, including biomarkers. Proven track record of clinical trial and project management experience; proven ability to work well on teams.Excellent oral and written communications skills in English. Expertise in MS Office applications including Excel, Word and PowerPoint.Organization, attention to detail and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills. Experience interacting with various levels within the organization, as well as vendors. Demonstrated ability to run meetings, work collaboratively in a cross-functional environment and drive for success.Experience with and/or willingness to manage and mentor direct report(s).Scientific knowledge of the therapeutic area to be supported, a plus.Project Management certification preferred.Ability to work in a fast-paced, complex environment with minimal supervision. Equal Opportunity Employer We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. Fraud Alert Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.