Clinical Trial Manager/Senior Clinical Trial Manager
About the Company:
Surface Ophthalmics is a pharmaceutical company focused on development and commercialization of innovative therapeutics for ocular diseases. Our current drug pipeline, all of which use a patented delivery vehicle, consists of three proprietary drug candidates for the treatment of: i) mild to moderate dry eye disease (DED), ii) acute DED, and iii) pain and inflammation for patients recovering from ocular surgical procedures. Together our product candidates address a multibillion-dollar market in the U.S and around the world. We are a start-up company with a small, closely-knit team. As we grow our programs and operational complexity, we are adding key positions to support our business.
Surface is headquartered in Pleasanton, California and offers a hybrid office & home work environment for most positions. The people at Surface are a dedicated, fun, and caring group to work with. We value initiative, collaboration, transparency, integrity and a drive for achieving our common objectives.
About the Opportunity:
A Clinical Trial Manager (CTM) focuses primarily on responsibilities of Clinical Operations related to study execution, taking care of day-to-day clinical trial activities, ensuring that the deliverables of Clinical Operations are consistent with the study protocol and the clinical development plan., with the possibility of a specified amount of additional functional management and/or departmental infrastructure responsibilities.
A Senior CTM (Sr. CTM) will be accountable for leading the cross-functional study execution, including Clinical Operations, ensuring study deliverables consistent with the study protocol and the clinical development plan. A Sr. CTM will provide overall project oversight for timelines, budgets, quality, resourcing and risk management and will be responsible for escalating study issues and risks to the VP of Clinical Operations.
Depending on experience level, competency and available capacity, a Sr. CTM may take on an additional role of study leader on another study. The role would depend on study size, phase of development, and complexity.
A CTM/Sr. CTM may also participate/lead departmental, development, or cross-functional initiatives.
- Lead all day-to-day Clinical Operations/cross-functional Study activities – start-up, enrollment, maintenance and close-out phases
- Serve as standing member in the cross-functional Project Team Meeting, representing Clinical Operations
- Participate/oversee the development, approval and maintenance of study plans, study manuals, study documents, study-specific training materials, ICF template
- Contribute to detailed study timeline and execute Clinical Operations responsibilities
- Manage the Clinical Operations function of Contract Research Organization (CRO) vendor
- Oversee training of CRO monitors (CRAs) and CRO monitoring performance
- Oversee the management of specialty vendors including budget(s) and coordinate periodic CRO/vendor project reviews
- Review eCRF and participate in Clinical Operations user acceptance testing (UAT)
- Be accountable for enrollment stimulus strategies
- Participate/lead in the internal data review activities required of the Clinical Operations team member(s)
- Manage monitoring visit report review, trend identification, issue resolution
- Manage protocol deviation review – preventative action planning, immediate escalation of significant concerns to VP of Clinical Operations and Medical Monitor
- Manage review of study risks – preventative action planning, immediate escalation of significant concerns to VP of Clinical Operations and Medical Monitor
- Provide clinical supply projections, coordinate approval of clinical supply demand and participate in Interactive Response Technology (IRT) system’s UAT
- CTM: Bachelor of Science or Bachelor of Arts degree in a relevant scientific discipline (or equivalent) and 6+ years of relevant clinical research experience the pharmaceutical, biotechnology, and/or CRO industries
- Sr. CTM: Bachelor of Science or Bachelor of Arts degree in a relevant scientific discipline (or equivalent) and 8+ years of relevant clinical research experience the pharmaceutical, biotechnology, and/or CRO industries
- Strong working knowledge of and experience in clinical drug development in the pharmaceutical, biotechnology, and/or CRO industries, including for example clinical research study planning, execution, and reporting; project and site management; site monitoring/monitoring oversight and quality processes; vendor/CRO management, as well as budget negotiations and management
- Strong working knowledge of regulatory requirements (e.g., FDA regulations, ICH GCP, and other requirements applicable to clinical research studies)
- Experienced author of study documents
- Excellent computer skills (Microsoft Office Suite, IRT/EDC/eTMF applications)
- Flexible team player who demonstrates the following competencies:
Collaborate: Participate and actively contribute to a joint effort of multiple individuals to accomplish a task or project. Understand and pursue mutually beneficial working relationships to move projects toward objectives. Build relationships with others and show consideration; treat others sensitively, fairly, and consistently.
Communicate: Understand the views of others and communicate in a realistic and practical manner using appropriate language. Listen attentively to views and issues of others. Share information in a timely manner that impacts others. Select appropriate methods of communication for each situation and communicate with respect, clarity, transparency, and honesty.
Deliver on commitments: Deliver on deadline and scope commitments with high quality outcomes. Be trustworthy in team situations and set appropriate expectations for work planning. Hold self and others accountable for delivering on goals and commitments. Actively seek clarity if expectations are not clear. Operate transparently and share accountability through active collaboration with others across functions.
Proactively plan and organize: Organize time effectively, create work schedules, prioritize, prepare in advance, and set realistic timescales. Visualize a sequence of actions needed to achieve a specific goal and how to estimate the resources required. Anticipate and adjust to change. Look for patterns and trends from diverse perspectives. Proactively adjust behaviors, plans to accommodate changes.
Solve problems: Analyze situations, diagnose problems, identify the key issues, establish and evaluate alternative courses of action and produce a logical, practical and acceptable solution. Take an overview and identify patterns, trends and long-term possibilities. Understand, link and analyze information to understand issues, identify options and support sound decision making. Seek ways to provide added value. Demonstrate recognition and development of new ideas and opportunities. Think critically about how to do things better and encourage new approaches and ideas.
Adapt: Welcome alternative thought processes, methods and approaches to problem.
Keep composure: Exercise self-control under trying or tough circumstances or situations or under any kind of pressure. Deal with interpersonally and/or politically challenging situations calmly and diplomatically, diffuse tension. Remain focused, try to think clearly and take appropriate decisions even under ambiguous, doubtful, stressful, dilemma and crisis situations. Thoughtfully intervene in conflicts to facilitate communication and resolve problems, find common ground when possible. Motivate others to concentrate on finding solutions to problems rather than getting overwhelmed by stresses and strains involved. Exude calming effect on the people around.
What’s in it for you:
Our employees enjoy benefits that make them more productive and contribute directly to the development of their professional skills. We want to be able to attract the best of the best and make sure they keep getting better. On top of an exciting and intellectually challenging workplace, we are offering:
- Work in a highly dynamic industry with a company focused on innovative science
- A hybrid home/office work schedule
- Collegial and supportive colleagues in a fun environment where personal development and success are high priorities
- Competitive medical / dental / vision packages
- 401K with company match
Surface is an equal opportunity employer. We want applicants of diverse backgrounds and hire without regard to race, color, gender, religion, national origin, ancestry, disability, age, sexual orientation, or any other characteristic protected by law.
Please send your resume and brief cover letter to: firstname.lastname@example.org.