Temporary Clinical Study Manager

Corbus Pharmaceuticals; United States; Hybrid; USD 100,000 - 130,000; Full time

Job summary

A biopharmaceutical company is seeking a Temporary Clinical Study Manager responsible for executing clinical trials and leading study teams. The ideal candidate will have extensive experience in clinical study management, project management skills, and a strong understanding of regulatory compliance. This role offers hybrid options for location and requires leadership in managing clinical studies from conception to reporting.

Qualifications

• Minimum of 8 years clinical study management experience in biopharmaceutical industry.
• Experience managing metabolic clinical programs through phase 1-4, particularly obesity trials.
• Advanced knowledge of GCP and current US, EU, and UK regulations.

Responsibilities

• Drive the successful execution of all operational components of a study.
• Develop and manage study budget within financial goals.
• Prepare study-related documentation and manage study-related vendors.

Skills

Clinical study management

Project management

Leadership skills

Excellent communication

Education

Bachelor’s Degree in health or biologic science

Job description

Direct message the job poster from Corbus Pharmaceuticals

The Temporary Clinical Study Manager is responsible for the successful execution of clinical trials from protocol conception through to clinical study report. The Temporary Clinical Study Manager ensures completion of study deliverables and proactively identifies and resolves clinical project issues. This role is accountable for leading the extended clinical study team and supporting the strategic planning and execution of clinical trials ensuring compliance with regulatory and legal requirements, ensuring high quality execution, clinical trial participant safety and data integrity.

This role can be hybrid to Norwood, Ma or remote.

Primary Responsibilities

• Clinical operations leader who drives the successful execution of all operational components of a study, using strong project management, leadership and organizational skills.
• Develop comprehensive study timelines and metrics.
• Develop and manage study budget within financial goals.
• Management of risk associated with KPI and issue escalation.
• Prepare and present project briefings, as required; plan, execute, and lead or participate in study-specific meetings.
• Coordinate and participate in periodic data quality review and may contribute to interpretation of clinical trial results.
• Coordinate with Data Management, Statistics, Medical and other functions for full life cycle management of clinical trial activities.
• Identify and assist in selection of external vendors required and develop vendor specifications. Review and prepare vendor reports related to vendor proposals with recommendations.
• Assist in the selection and evaluation of study personnel (contract and internal).
• Provide or facilitate study-specific training to clinical research staff, and other contract personnel.
• Manage study-related vendors and serve as the primary point of contact for all contracted vendors (CROs, SMOs, Labs, Meeting Planner, etc).
• Identify potential risks and resolve issues with CROs while establishing vendor management plans and reviewing quality metrics.
• Participate in site and country selection. Review completed feasibility questionnaires to assist with site selection. Develop relationships with investigators and site staff.
• Prepare and review site study documents: site-specific informed consent, study tools/worksheets, investigator contracts and site payments.
• Oversee clinical monitoring activities, ensuring compliance with (GCP) and applicable regulations.
• Participate in site co-monitoring visits as appropriate.
• Support the design of clinical trial protocols along with the study team and consistent with the clinical development plan.
• In collaboration with the Clinical Scientist, develop ongoing data review plan to ensure data trend detection and study objectives are met.
• Prepare study-related documentation; provide input for the design of ICF template, CRFs, monitoring conventions, edit checks, etc.
• Prepare and/or review study-related documents including the Site Performance Plan, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and Risk Mitigation Plan.
• Provide input and support documentation for adverse event safety monitoring while collaborating on FDA and regulatory authorities report submissions.
• Coordinate with CMC or Clinical Supply to facilitate study drug manufacture, packaging, labeling and distribution.
• Participate in planning of QA activities and coordinate resolution of audit findings.
• Ensure audit-ready clinical trial documentation including central clinical files. Review monitoring reports, ensuring quality and resolution of site-related issues.
• Coordinate and assist regulatory or ethics committee activities planning.
• Provide oversight to maintain clinical trial master files and ensure appropriate compliance and completeness.
• For any study CAPA raised perform a root cause analysis, as well as drive all actions to completion, within the expected timeframe.
• Lead and consistently be present for the Cross-Functional Study Team as well as for internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.).
• May represent Clinical Operations in other cross-functional activities or participate in functional initiatives in support of departmental objectives.
• This role reports directly to the Senior Director, Clinical Operations.

Qualifications

• Bachelor’s Degree (health, biologic science or related field) required.
• Minimum of 8 years clinical study management experience in biopharmaceutical industry, including at least 5 years as a clinical study lead/project manager, required.
• Prior experience managing contracted resources/CRO required.
• Experience managing metabolic clinical programs through phase 1-4, experience with obesity trials would be ideal.
• Site monitoring and clinical data review experience highly preferred.
• Clinical quality compliance experience highly preferred.
• Advanced knowledge of GCP and current knowledge of US, EU and UK regulations.
• Knowledge of ICH and other country regulatory requirements is preferred.
• Excellent communication, organizational, problem-solving, conflict resolution, leadership and team-building skills required.

About Corbus

Corbus is a close-knit global team of high-achieving, innovative, creative, and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.

Corbus is an oncology and obesity company committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ internal development pipeline includes CRB-701, a next-generation antibody drug conjugate (ADC) that targets the expression of Nectin‑4 on cancer cells to release a cytotoxic payload, and CRB-601, an anti‑integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. Additionally, we are developing a cannabinoid receptor‑1 (CB‑1) inverse agonist as a potential treatment for obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com and connect with us on Twitter, LinkedIn and Facebook.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.