DescriptionHeadquarters Location: Emeryville, CA
Candidate Location: Hybrid
Travel Required: 5%
Reports To: VP, Clinical Operations
Department: Clinical Operations
Position Type: Full-time
Who You Are and What You'll Do:You are passionate about life sciences and making a difference to cancer patients, their families, and healthcare providers. You will be responsible for providing operational and scientific support for clinical studies. This cross-functional role includes working directly with the study team and vendors to ensure execution on the clinical strategy, as well as assembling, evaluating, and presenting operational data. The Clinical Trial Manager will report to the Vice President, Clinical Operations and collaborate closely with Clinical Development, Clinical Pharmacology, Biostatistics, Data Management, Sample Management and Program Management.
Job Responsibilities: - Develops and manages the execution of clinical trial operational activities to ensure completion according to timelines while anticipating potential study problems and preparing contingency plans as needed.
- Works directly with study team and/or vendors on development of study documents, plans and manuals including but not limited to: protocol and amendments, investigator brochure, informed consent form, annual reports, clinical study report, pharmacy manual, laboratory manual and internal data review plan.
- Develops and ensures compliance with clinical monitoring plan and associated key performance indicators (KPIs).
- Reviews monitoring trip reports and ensures accurate identification, tracking and resolution of all protocol deviations and action items.
- Collaborates with the clinical development team to ensure appropriate data review and accurate data reporting.
- Procures and manages contracts with CROs, study vendors and investigative sites.
- Provides vendor oversight of assigned clinical trial vendors.
- Reviews and approves vendor and investigative site invoices.
- Manage, either directly or through supervised delegation, other study-wide activities such as sample handling, drug re-supply and investigator payments.
- Provides frequent study updates to management upon request.
- Partners with study team to ensure trial activities are documented in the trial master file in accordance with regulatory requirements and SOPs.
- Collaborates cross functionally in the preparation of scientific publications including posters, abstracts, and manuscripts.
- Supports the implementation of new clinical SOPs, systems and processes.
- May mentor, manage and develop other team members.
Minimum Qualifications: - A minimum of a Bachelor's degree in clinical, biological, mathematical sciences or related field is required, an advanced degree is preferred.
- A minimum of 5 years pharmaceutical development experience is strongly preferred with 3+ years of CTM or study lead experience.
- Oncology experience is required, gastrointestinal cancer experience is strongly preferred.
- Prior experience managing or leading Phase I oncology trials is required.
- Veeva Vault or similar system experience is strongly preferred.
- Demonstrated experience operating in a small or early-stage biotech environment with direct hands-on ownership of study execution (not soley CRO oversight), is required.
Preferred Qualifications: - Must have demonstrated problem solving abilities and strong organizational skills.
- Excellent written and verbal communication skills are required.
- Experience and understanding of ICH and GCP is preferred.
- Must be a demonstrated self-starter and team player with strong interpersonal skills.
How You Will Work: - Demonstrates collaboration and teamwork. Works well with others and understands that collaboration leads to better results.
- Possesses strong communication skills. Communicates clearly, concisely, and professionally. Listens actively to build understanding.
- Exhibits strong interpersonal skills and self-awareness. Builds and cultivates strong and enduring relationships with others. Acts with humility and understands own strengths and weaknesses.
- Shows continuous improvement and a commitment to self-management and development. Operates with a continuous improvement mindset and continuously seeks to expand own knowledge and capabilities.
- Demonstrates a patient focus. Puts the patient first in actions and decisions taken.
Compensation, Benefits, and So Much More - The expected salary range for this role based on the primary location for this position in California is $135,000 - $165,000 per year. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job-related factors permitted by law.
- A great environment where we work collaboratively, leverage each other's strengths, and work toward a shared vision with our common goals of doing the best thing for patients.
- A robust and enduring approach to your development and career growth fueled by a strong learning curriculum and career guidance that helps you understand how you can grow your career at CytomX.
- A robust and highly competitive total rewards program that helps you achieve your compensation goals while supporting a great work / life balance.
Conditions of Employment - Background investigations are required for all positions at CytomX, consistent with applicable law.
