Clinical Trial Transparency Manager

Hobson Prior are currently working with a global pharmaceutical organisation who are driven to help improve and prolong life. Our client is seeking a Clinical Trial Transparency Manager to join them on a contract basis in Darmstadt.

Job Responsibilities:

• You will ensure Compliance with all global applicable laws, regulations and internal policies in regard to Clinical Trial Disclosure.
• Lead different disclosure activities related to the organisations Clinical Trails.
• Pounced knowledge of PharmaCM Disclosure system is a must.
• Administrated ClinicalTrials.gov and EudraCT accounts for the organisations sponsored clinical trials.
• Deliver updates for all posted sponsored clinical trials.
• Act pro-actively on any Clinical Trial Disclosure topics including but not limited to Responsible Data Sharing, Lay Patient Summary or Policy 0070 issues to ensure compliance.
• Provide expert support for internal stakeholders.
• Represent as Subject Matter Expert for a respective Clinical Trial Disclosure training.
• Partake in internal and external continuous improvement activities.
• Responsible for management of the vendor/s responsible for outsourced activities related to Clinical Trial Disclosure.
• Support internal audit and inspection activities as required.
• Deliver on the regular basis reports of metrics related to tracking and monitoring clinical trial Disclosure activities.

Key Skills:

• Task orientated and able to prioritize them.
• Ability to work independently and possessing good time management skills.
• Proven Project Management skills.
• Strong communication skills.
• Solid analytical skills.
• Ability to identify risks and develop mitigation strategies or anticipate and resolve issues even in complex situations.

Requirements:

• Bachelor's degree in Life Science is essential.
• Minimum 5 years of experience in the clinical development and/or regulatory affairs area within the biopharmaceutical industry or a contract research organization.
• A minimum of 2-3 years Previous experience in Clinical Trial Transparency is a must.
• Knowledge of clinical trial disclosure and responsible data sharing area.
• Comprehensive knowledge of ICH-GCP, FDA, EMA and ROW regulation related to the Clinical Trail Transparency.
• Knowledge of Clinical Trial Disclosure Systems (PahrmaCM).

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.