Clinical Trial Manager/Senior (CTM) (Contract)
Redwood City, CA
Research & Development – Clinical Operations /
Full Time /
Remote
Note to Recruiters and Agencies
The Talent Acquisition / HR team manages the recruiting for all positions at Adverum. We only accept resumes from search agencies or recruiters if the Talent Acquisition / HR team has formally requested your help and have a signed agreement in place. Unsolicited resumes sent to Adverum will be considered property of Adverum. The company will not be responsible for any associated fees should Adverum hire from unsolicited resumes. We request that recruiters do not to contact or present candidates directly to our hiring managers or employees. Doing so may jeopardize the candidate’s eligibility to work on future positions. Recruiters interested in working with Adverum can submit their information to hr@adverum.com. Should we have a tough-to-fill role, we will contact you directly if you specialize in the needed area.
The Clinical Trial Manager/Senior (CTM) will be responsible for supporting all phases of the company’s clinical research function, including planning, implementation, completion, and final reports of clinical trials, data collection, and data management systems across all clinical indications and therapeutic areas in compliance with appropriate standard operating procedures, regulatory and medical standards. Provides operational and implementation expertise, in collaboration with other team members, regarding the adequate design, planning, and implementation of the clinical development strategy, including appropriate oversight and timely execution of the clinical plans. Ensures documentation of product trials, analysis, and reporting to prepare documentation required for including in the company’s regulatory product submissions.
This is a contract position: 6 months to start
What you'll do:
- Serves as primary study team contact to manage the start-up, conduct, and close-out of clinical studies.
- Leads the cross-functional study execution team to ensure that project milestones are met and adhere to approved budgets and are in compliance with ICH/GCP and local Regulatory Authorities
- Helps with the development, planning, and forecasting of budget requirements for the clinical programs and clinical study sites.
- Manages CRO and vendor evaluation, selection, training, and oversight
- Facilitates site feasibility/selection processes.
- Conducts Sponsor quality monitoring/oversight visits to sites as needed.
- Provides strategic and operational input into the development of study documents including the study protocol, ICF, CRFs, pharmacy manual, laboratory manual, etc.
- Oversight of preparation and submission of safety reports (pharmacovigilance)
- Supply chain management. Forecast and manage investigational drug labeling, packaging and distribution.
- Ensuring clinical record keeping in preparation for audits and inspections.
- Identification and engagement of thought leaders, investigators, cooperative groups, and other experts regarding the latest clinical thinking, study design, study conduct, and interpretation of study results.
- In conjunction with data management, assist with eDC development, preparation and/or review of data listings, issue and query resolution.
- Collaborate on the development and set-up of study systems (e.g. IVRS/IWRS, site payments and CTMS).
- Develops and reports key executional metrics for the oversight of the clinical trials.
- Assists with creating, reviewing and implementing SOPs and processes in clinical development.
About you:
- Bachelor’s degree preferred. Certification in health-related field or Associates degree required. Preference in a health care or scientific discipline.
- At least 5-8 years clinical research experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting.
- Excellent verbal, written communication skills and interpersonal and presentation skills are required.
- Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience with email and calendar programs. Experience with IVRS and EDC systems a plus.
- Knowledge of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials; Phase 3 experience is a must
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well defined instructions and procedures.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools.
- Strong attention to detail and excellent organization skills.
- Strong interpersonal skills and communication skills (both written and oral) able to work effectively in a team/matrix environment.
- Experience in ophthalmology, gene therapy and/or rare disease indications highly preferred
$60 - $85 an hour
This is a contract role, starting out at 6 months. Hourly rate will depend on experience and location.
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery, and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create a space that allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions, and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation
