Clinical Trial Manager

Clinical Trial Manager

South San Francisco, CA /

Clinical Operations /

Full-time

/ Hybrid

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer . Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

As a Clinical Trial Manager in the clinical operations team, you'll work cross functionally, both internally and externally to support Alector clinical development programs. You will contribute as a member of the study team and across the broader Clinical Operations department. You will apply your technical and interpersonal skills and experience to clinical trial planning and execution.

The CTM will be responsible for documenting and reporting to meet regulatory requirements of a clinical development program. They will work directly with the Clinical Operations Study Lead and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget.

During your first year, your responsibilities will include:

• Supporting the Study Lead in clinical trial planning through interaction with vendors and internal team members
• Executing on key clinical trial activities such as investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and tracking of important metrics
• Vendor management including CROs, central labs, imaging, COAs, IRT
• Creating study plans/manuals, review of Investigator's Brochure, Protocol and other essential documents
• Plan resources and tasks to meet program objectives for timely initiation and completion of clinical studies
• Develop and review SOPs and guidelines for compliance with global regulatory requirements, including establishing appropriate processes and procedures to conduct global clinical trials
• Establish systems for tracking various activities during clinical trials, e.g., tracking of patient status, enrollment, data query resolution, etc.

We'd love to hear from you if you have:

• Experience working on global Phase I-III clinical trials, particularly with a focus on Neuroscience, Oncology, orphan/rare diseases and/or Immunology
• Excellent project management skills and In-depth knowledge of ICH GCP guidelines
• An academic background that includes a Bachelor's with 4+ years of experience in clinical study management within a Pharmaceutical, Biotechnology company or at a CRO
• Experience managing clinical trials, including CROs, consultants, and vendors specific to the therapeutic areas (Neuroscience, Oncology)
• Take pride in being a team player, savvy, self-motivated, and efficient
• Demonstrate a track record of being a self-starter and troubleshooting independently
• Thrive in an environment where work is done both independently and on teams

#LI-FS1

#LI-Hybrid

Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

Alector was named on Fortune's " Best Workplaces in Biopharma " top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022 .

Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other's assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.