Sr. Clinical Trial Manager
The Sr. Clinical Trial Manager is responsible for the execution of clinical studies to required quality standards, ensuring the integrity of the clinical data on schedule and within budget for phase I-IV clinical trials by overseeing and managing vendors, junior staff, and contractors with a 1-2 year horizon.
Manage all day-to-day operations of
· Overall operational execution of global clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.).
· Manage aspects of a clinical trial from start-up through completion, including writing protocols, informed consent documents, and contributing to clinical sections of Investigator Brochures.
· Responsible for site and vendor feasibility, capabilities assessment, selection, management, and oversight.
· Manage the implementation, on-time execution, and conduct of clinical studies, including contributing and tracking the development of budget items, milestones, and timelines, in addition to contributing to the scope and management of resources (including vendor selection). All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.
· Coordination of cross-functional study team members (bio stats, clinical pharmacology, data management, medical monitors) to ensure initiation and execution of the clinical study deliverables within the approved budget and timelines.
· Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished on time.
· Provide recommendations in vendor identification/qualification/selection and oversight with a proven track record of successful execution and study completion activities.
· Contribute to or lead the systems set-up/management including EDC, IWRS, Central Laboratories, and specialty services (ePRO, eDiary, etc.).
· Understanding of how to review, oversee and deliver the trial endgame, which is the data and statistical analyses by critically assessing data to detect trends and outliers to efficiently direct resources and attention to correct problems early.
· Ensure data integrity through oversight of routine data reviews, query and resolution, consistency checks both internally and for independent data monitoring committees.
· Effectively tracks and communicate (verbally and in writing) program/study progress to Portfolio/Program Directors and Senior Management with ability to create and update detailed dashboards and trackers.
· Responsible for timely submission of documents to TMF.
· Awareness of disease/ treatment landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary.
· Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials.
Professional Experience /Qualifications:
· Demonstrated experience in core and technical aspects of initiating and managing phase 1-4 clinical trials.
· Demonstrated experience in management of sites, CROs and vendor selection.
· Demonstrated willingness to be hands-on and perform tasks within tight turnaround time.
· Possessing excellent interpersonal and communication skills, with developing leadership attributes.
· Success working in a matrixed environment.
· Demonstrated experience in the application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards).
· Experience in data collection, monitoring, cleaning, and analysis throughout clinical development (Phase 1-4).
· Proficiency in Microsoft Office (Word, Excel, Outlook, and Project), electronic TMF, and electronic clinical technologies.
· Able to multi-task in a fast-paced environment.
· Able to build strong cooperative relationships with coworkers.
· Listens, seeks common ground and establishes credibility.
· Author complex documentation with minimal supervision.
· Possess a high degree of attention to detail.
· Proactive and accountable.
· Previous employment at a pharmaceutical, biotech company or CRO preferred.
B.A. or advanced degree in biological science or life sciences discipline.
Certifications a plus ex. Project Management Professional, Clinical Trials Design and Management, etc.
At least 6 years of relevant experience in clinical operations. Experience in both early and late phase of development preferred. Comfortable with travel and able to travel up to 25% of the time as needed.
Preferred Computer Skills:
Thorough working knowledge of personal computer systems and desktop office applications.
· We Elevate
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· We Nurture
This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
Alumis Inc. is an equal opportunity employer.
If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID -19 vaccine and at least one booster or have a valid religious or medical reason not to be vaccinated.