Sr. Clinical Trial Manager, Clinical OperationsLocation San Rafael, California Apply
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 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 – 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’s 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’ lives.
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
With advanced knowledge and experience in the following core and technical competencies:
- Agility and Proactivity
- 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 and enrollment
- Study outcome and data deliverables
- Study closeout
- 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:
- 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.)
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.
In the U.S., the salary range for this position is $ 137,000 to $ 205,400 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.