Senior Manager, Clinical Project Management

February 10

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CG Oncology

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CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative oncolytic immunotherapies for patients with bladder cancer. The company's primary investigational product, cretostimogene grenadenorepvec, aims to provide a bladder-sparing therapeutic option, enhancing the quality of life for afflicted patients. With ongoing clinical studies highlighting the potential benefits of their therapies, CG Oncology strives to address the unmet needs in bladder cancer treatment.

Immuno-Oncology

51 - 200 employees

Founded 2010

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• Manages study timelines and metrics; participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; prepares and presents project debriefings, as required; plans, executes, and attends/manages study-specific meetings as applicable. • Partners with the Clinical Research Organization (“CRO”) to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed; revises scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. • Oversees all study-level data monitoring activities; reviews visit reports; attends monitoring visits as required. • Responsible for monthly Protocol Deviation (PD) review, including oversight of CRA documentation and collaboration with Medical Monitor for medical review. • Responsible for coordination and oversight of clinical data and listings review for assigned trials. • Works in a team environment comprising of clinical operations, regulatory, technical operations, quality, and CROs to assess and meet data management needs; including ensuring data is accurately collected in an efficient and timely manner. • Uses operational and therapeutic expertise to optimize trial design and execution; works with the study team to design clinical trial protocols and assists in developing/managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; supports the creation of the ICF template, CRFs, etc. • Prepares and/or reviews study-related documents. Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments). • Responsible for the management of study budget and maintains it within financial goals, including review of invoices against approved budget. • Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate. • Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function. • Mentors, leads and supervisors other Clinical Trials roles to achieve both role and team objectives.

🎯 Requirements

• Seven (7) years or more of progressive clinical management experience with the biotech / pharmaceutical industry or in a clinical research organization. • Three (3) years of experience in full-cycle drug development required including participation in multi-disciplinary project teams working on phase I-IV global clinical studies. • Prior experience supporting regulatory filings, inspections, and audits. • Available for approximately 25% travel both domestic and international, including overnight stays. • Small biotech experience preferred

🏖️ Benefits

• FULLY REMOTE WORK ENVIRONMENT • REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off • HOLIDAYS –In 2025 we will observe 14 holidays • RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary • HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal • HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC • ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans • LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans • ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More