Clinical Development Program Manager

Thyroxine SERB; Conshohocken (Montgomery County); Sur place; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Vacation, Personal and Sick time

15Paid Company Holidays

Medical, Dental, Vision benefits

Tuition Assistance

Discretionary Bonus Plan

401(k) with company match

Résumé du poste

SERB is seeking a Manager of Clinical Development to lead the end-to-end operation of clinical studies, including budgeting, planning, and CRO/IIS oversight. You will ensure regulatory compliance and maintain vendor relationships within an ambitious portfolio of products across geographies.

The role requires strong leadership, written and verbal communication, and the ability to manage multiple trials and priorities while upholding ethical standards and the company’s medical purpose.

Qualifications

• University degree in a health-related field.
• Minimum of three years direct clinical trial experience in a CRO or research-related organization.
• Experience with in-vitro diagnostic studies would be beneficial.
• EU experience would be beneficial.

Responsabilités

• Manage all aspects for company sponsored and IISs according to SOPs and ensure compliant processes.
• Ensure projects comply with the protocol, GCP, and applicable regulations.
• Supervise outsourced tasks and manage contractor relationships with oversight of vendors.
• Draft study documents such as synopsis, protocols, informed consents and study plans per SOPs.
• Prepare clinical study budget and manage studies to approved budget.
• Ensure regulatory documents are obtained and study files comply with GCP and SOPs.
• Update and draft SOPs as required.
• Negotiate contracts for IISs with legal and sites.
• Maintain current knowledge of FDA regulations, GCP, and ICH Guidelines.
• Maintain high ethical and professional standards in all engagements.
• Carry out additional tasks as required by Line Manager.

Connaissances

Clinical Development

GCP Knowledge

Budget Management

Vendor Management

Contract Negotiation

Regulatory Knowledge

Formation

Bachelor's degree in health-related field

3+ years direct clinical trial experience

Outils

EDC (Electronic Data Capture)

Description du poste

SERB is seeking a Manager of Clinical Development to lead the end-to-end operation of clinical studies, including budgeting, planning, and CRO/IIS oversight. You will ensure regulatory compliance and maintain vendor relationships within an ambitious portfolio of products across geographies.

The role requires strong leadership, written and verbal communication, and the ability to manage multiple trials and priorities while upholding ethical standards and the company’s medical purpose.