Clinical Trial Manager

3 weeks ago

Brisbane, United States Vera Therapeutics Full time

**Title: Clinical Trial Manager**

**Location**:Brisbane, CA**

**About Us**:
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

**Position Summary**:
The Clinical Trial Manager will report to the Senior Director, Clinical Operations and will be responsible for planning, execution, and oversight of key aspects of clinical studies. The role involves integration across internal and external teams to ensure studies are managed to the highest quality. The Clinical Trial Manager will work within the Clinical Operations team and cross functionally with other departments.

**Responsibilities**:

- Manages assigned parts (vendor and/or global region) of studies of large scope and high complexity
- Participates in cross-functional groups within the Company to address trial problems based on a under general supervision
- Recognizes and escalates issues on a study that may impact the execution of a study
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies
- Assist in the review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts, and clinical study reports
- Provides assistance in the oversight and/or management of site selection, study implementation and ongoing coordination of study sites, either directly or via CROs
- May conduct site evaluation, initiation, monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
- Mentors and trains more junior team members CTMA/CPA
- Travel as required. 10-20% domestically
- Excellent interpersonal skills, ability to lead multifunctional teams, ability to manage staff, and mentor junior staff is required
- With support, effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions

**Qualifications**:

- Bachelor’s Degree or equivalent experience
- 4 years of clinical trial experience within clinical operations at a biotech or pharmaceutical company
- Collaborative demeanor
- Strong ability to work with cross-functional team members and external vendors
- Exceptional organizational skill and communication skills, both spoken and written
- MS Office knowledge and experience with Word, PowerPoint, and Excel

Vera Therapeutics Inc. is an equal opportunity employer.

**COVID-19 Policy**

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We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.

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