Job Description
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard \u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. BioMarin\u2019s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients\u2019 lives. Role SummaryFor assigned study(ies), the Sr. Clinical Trial Manager is accountable for day-to-day Clinical Operations study execution and related deliverables and is the primary point of contact within Clinical Operations for a study. Key responsibilities include managing risks, issues and opportunities that impact timeline, quality, and budget, overseeing the Clinical Operations study team, vendors and CRO, and collaborating with cross-functional representatives to execute on study deliverables. The Sr. CTM is responsible for complex, pivotal/registration phase III, or late-stage studies requiring greater depth of clinical development experience. The Sr. CTM plays a greater role in supporting the Clinical Program Lead (CPL) in program wide activities, engaging with leadership, and leading Study Execution Team (SET) activities.Within the role the candidate is expected to show and have proficiency and experience in the following core and technical competencies:\u00A0 Decision Making, Strategic Thinking, and Problem Solving Influence and Organizational Awareness People ManagementData Analysis and InterpretationWith\u00A0advanced knowledge and experience in the following core and technical competencies: Agility and Proactivity Leadership Communication and Collaboration Study Management and Execution\u00A0 Compliance and Quality Drug Development and Study Design\u00A0 Product and Therapeutic Area Knowledge\u00A0Responsibilities include but are not limited to: Overall study execution oversight Provide leadership, guidance and direction to Clinical Operations staff assigned to study Facilitate cross-functional Study Execution Team (SET) meetings as delegated. May serve as an agenda driven member of the Clinical Development Team (CDT) Collaborate with cross-functional study members to execute on study deliverables Ensure cross-functional development of key study plans (e.g., monitoring plan, data management plan, safety plan, etc.) Proactively identify and communicate Clinical Operations and cross functional study risks and mitigations; align with cross-functional Study Execution Team on overall Risk Mitigation Plan Identify, manage, and escalate study risks, issues and opportunities that impact timeline, quality, and budget Provide regular study quality and progress updates to key stakeholders as needed; Monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate Collaborate with other Study Managers to ensure creation, consistency, and maintenance of the various study plans within a program Collaborate with line managers of CTS staff to support team member productivity and career growth Other responsibilities to cover: Study protocol and Informed Consent Form (ICF) development Study resource planning Study timelines Vendor oversight Study start-up \u2013 site selection and activation Drug / Investigational Product (IP) Study quality Study budget oversight Recruitment and enrollment Study outcome and data deliverables Study closeout Insurance Program-wide initiatives Lead or participate in study-specific projects that have a wider program impact Collaborate with study managers/cross-functional team members to implement process change and efficiencies across programs as required? Education & Experience: BA/BS/BSc 7 years\u2019 work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.) PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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