Study Manager

3-5 years

Not Disclosed

Princeton Junction

15 June 12, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Clinical Trial Manager

Summary

The Clinical Trial Manager is responsible for planning and executing one or multiple global trials. This includes managing all aspects of trial deliverables such as timelines, budgets, recruitment, country/site selection strategies, and provision of clinical trial materials. The role serves as the main contact for cross-functional teams, CROs, vendors, and study sites.

Requirements

Education: Bachelor’s degree in biological sciences or equivalent.
Experience: 3-5 years of relevant clinical trial management and leadership experience in the pharmaceutical, biotechnology, CRO, and/or healthcare industry.
Skills:
- Excellent communication skills.
- Command of medical terminology.
- Knowledge of scientific/medical and clinical concepts used in Phase I-IV clinical trials.

Responsibilities

Trial Management

Plan and execute global trials, managing all aspects of trial deliverables.
Develop timelines, budget, recruitment, and country/site selection strategies.
Provide clinical trial materials.
Serve as the main study contact for cross-functional teams, CROs, vendors, and study sites.
Monitor KPI and performance metrics, drive related discussions, and escalate risks/issues.
Report status to the clinical operation lead.

Documentation and Protocols

Participate in the preparation of protocols and Case Report Forms (eCRFs).
Author and coordinate study-specific documents such as Informed Consent.
Ensure compliance with the project plan and mitigate potential risks and issues.

Collaboration and Training

Work with CROs to develop processes and mitigation strategies.
Collaborate with Clinical Development and CRO on study-specific training for study teams and sites.

Financial Management

Responsible for the financial management of the clinical trial.
Monitor trial milestones and day-to-day operations, ensuring accurate information in internal electronic systems and reports.

Participant Recruitment and Data Management

Ensure timely recruitment of trial participants and efficient data management.
Oversee systems to track study, investigator, and ethical review board information, patient recruitment activity, and financial management.

Site Management

Lead site identification and selection in collaboration with internal medical leads and CROs.
Verify qualifications and resources of research staff and facilities.
Ensure proper setup of study sites with trial materials, investigational products, and training.

Compliance and Quality Assurance

Verify adherence to the approved protocol, SOPs, GCP procedures, and regulatory requirements.
Provide oversight of study CROs and vendor activities, including creating and managing CRO oversight plans.
Ensure inspection readiness of trial documentation and support Quality Assurance on site audits, CAPA, and inspection requests.

Meetings and Coordination

Manage and coordinate investigator meetings and cross-functional team meetings.
Lead selection, setup, and provide oversight to study vendors such as IRT, ePRO, ECG, Central lab, etc.

Additional Information

Aequor is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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Study Manager

Job Description

Job Description: Clinical Trial Manager

Company Information

Summary

Requirements

Responsibilities

Trial Management

Documentation and Protocols

Collaboration and Training

Financial Management

Participant Recruitment and Data Management

Site Management

Compliance and Quality Assurance

Meetings and Coordination

Additional Information

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