Clinical Trial Manager - Dach region

ICON Strategic Solutions; Deutschland; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global clinical research organization is seeking a Clinical Trial Manager in Germany to lead Local Study Teams and ensure timely delivery of clinical studies according to protocols and guidelines. The ideal candidate will have a bachelor’s degree in life sciences, at least 3 years' experience, and strong project management skills along with excellent verbal and written communication in English and German.

Qualifikationen

• Minimum 3 years of experience in Development Operations or related fields.
• Good knowledge of international guidelines ICH-GCP and local regulations.
• Excellent ability to prioritize and handle multiple tasks.

Aufgaben

• Has overall responsibility for the study commitments within the country.
• Leads Local Study Team consisting of CRAs, CTAs, and Study Start-up Specialists.
• Ensures timely preparation of financial Study Management Agreements.

Kenntnisse

Leadership

Project management

Interpersonal skills

Attention to detail

Communication skills

Negotiation skills

Ausbildung

Bachelor’s degree in related discipline, preferably in life sciences

Jobbeschreibung

Overview

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

Responsibilities

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRAs, CTAs, and Study Start-up Specialists for assigned study/studies.
• Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with SOPs, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in the clinical studies financial system by regular checks of the system and financial reports.

Qualifications

• Bachelor’s degree in related discipline, preferably in life sciences.
• Minimum 3 years of experience in Development Operations or related fields (Medical Affairs-led or Academic-led studies).
• Good knowledge of international guidelines ICH-GCP and local 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 skills.
• Excellent team building and interpersonal skills.
• Excellent organizational skills.
• Excellent verbal and written communication skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent attention to details.
• Excellent knowledge of spoken and written English and German.
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.
• Ability to travel nationally and internationally as required.