Sr. Clinical Trial Manager,Clinical Operations

BioMarinis the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. BioMarin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care, and providing personalized support and services globally.

Role Summary

For 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:

• Decision Making, Strategic Thinking, and Problem Solving
• Influence and Organizational Awareness

• People Management

Data Analysis and Interpretation

Withadvancedknowledge and experience in the following core and technical competencies:

• Agility and Proactivity
• Leadership
• Communication and Collaboration
• Study Management and Execution
• Compliance and Quality
• Drug Development and Study Design
• Product and Therapeutic Area Knowledge

Responsibilities 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 – site selection and activation
  • Drug / Investigational Product (IP)
  • Study quality
  • Study budget oversight
  • Recruitment andenrollment
  • 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 implementprocess change and efficiencies across programs as required?

Education & Experience:

•BA/BS/BSc

•7 years’ 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.)