Clinical Trial Manager - sponsor dedicated (80%)

Pharmaceutical Research Associates, Inc; Deutschland; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in clinical research seeks a Clinical Trial Manager to oversee local study teams and ensure the timely delivery of high-quality clinical study components. The ideal candidate will have a strong background in Development Operations, excellent project management skills, and fluency in English and German.

Qualifikationen

• Minimum 3 years of experience in Development Operations or related fields.
• Fluency in spoken and written English and German required.
• Good knowledge of ICH-GCP regulations.

Aufgaben

• Lead Local Study Team and ensure study commitments.
• Perform site monitoring and feasibility assessments.
• Coordinate site selection and prepare study budgets.

Kenntnisse

Project Management

Team Building

Interpersonal Skills

Negotiation Skills

Detail Orientation

Ausbildung

Bachelor’s degree in a related discipline

Jobbeschreibung

Overview

As a Clinical Trial Manager, you will lead the Local Study Team(s) at the country level to deliver committed components of clinical studies according to agreed resources, budgets, and timelines, while complying with Procedural Documents and international guidelines such as ICH-GCP, as well as relevant local regulations. In addition to leading local study teams, the CTM may perform site monitoring as needed to support the flexible capacity model.

Responsibilities

Key responsibilities include:

1. Having overall responsibility for study commitments within the country and for the timely delivery of data of required quality.
2. Leading the Local Study Team, which may consist of CRAs, CTAs, and Study Start-up Specialists, for assigned studies.
3. Leading and optimizing the performance of the Local Study Teams at the country level, ensuring compliance with SOPs, ICH-GCP, and local regulations.
4. Ensuring, as required, that clinical and operational feasibility assessments of potential studies are performed to the highest quality.
5. Coordinating the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessments, and conducting Site Qualification Visits to evaluate suitability and quality risks.
6. Ensuring the timely preparation of the country financial Study Management Agreement (fSMA) and maintaining an accurate study budget in the clinical studies financial system through regular checks of the system and financial reports.

Qualifications

• Bachelor’s degree in a related discipline, preferably in life sciences.

• Minimum 3 years of experience in Development Operations or related fields, such as Medical Affairs-led or Academic-led studies.

• Good knowledge of international guidelines (ICH-GCP) and regulations.

• Proven ability to lead and motivate cross-functional teams to deliver according to or ahead of time plan, budget, and with required quality.

• Excellent project management, team-building, and interpersonal skills.

• Excellent organizational, verbal, and written communication skills.

• Excellent ability to prioritize and handle multiple tasks with attention to detail.

• Fluency in spoken and written English and German.

• Good negotiation skills and ability to adapt to IT systems.

• Ability to travel nationally and internationally as required.