Ref #: 27486

Employment type: Fixed term - Full-Time

Location: Netherlands

Posted: 31-Mar-2021

Description

The Early Development & Clinical Pharmacology (ED&CP) Trial Manager I (TM I) is responsible for the local management of a trial in one or more countries and to deliver quality data and trial documents/records that are compliant with assigned clinical protocol, codes of Good Clinical Practice (GCP), Healthcare Compliance Requirements (HCC), Standard Operating Procedures (SOPs) and local regulatory requirements.

He/she acts as the primary point of contact at a country level for assigned studies.

Responsibilities:

• Besides the LTM tasks, a TM may also be responsible for GTL and SM tasks depending on the studies assigned. For the GTL and SM tasks reference is made to the Job Description for the ED&CP GTL and SM and the GCO Procedural Documents.

• Collaborates with the FM for performing study feasibility and site assessments, providing recommendation of suitable sites for selection to participate in the trial according to ED&CP decision tree. Ensures appropriate follow-up of pre-trial visit activities. Collaborates with the GPL (Global Program leader), GTL, FM and other study team members to select final sites list.

• Contributes to the development of study management documents at a country level or initiates development of these documents for trials which follow ED&CP Hybrid Oversight Model.

• Leads and coordinates local trial team activities in compliance with GCO SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting (if applicable).


Requirements:
• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.

• Minimum two years of clinical trial management experience (in addition of site monitoring experience) is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.

• Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing in the Dutch and English language. Good written and oral communication skills.



What is offered:
You will become part of one of leading company within the pharmaceutical industry. The client offers unique opportunity, professional working environment with focus on training and development opportunities. You will receive market conform remuneration package and other benefits.

Interested? Please send your English CV in a Word document to: Iris Brouwer (iris.brouwer@docsglobal.com)


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