Clinical Trial Manager, Clinical Operations

CytomX Therapeutics, Inc.•South San Francisco, CA

5d•$135,000 - $165,000•Hybrid

About The Position

CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody® therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX has a broad pipeline, which comprises seven therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies (“TCBs”), and immune modulators such as cytokines and checkpoint inhibitors (“CPIs”). Learn more at www.cytomX.com.

Requirements

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.
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.

Nice To Haves

Gastrointestinal cancer experience is strongly preferred.
Veeva Vault or similar system experience is strongly preferred.
Experience and understanding of ICH and GCP is preferred.

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.