Ref #: 25213

Employment type: Permanent - Full-Time

Location: Germany, Home Office possible.

Posted: 18-Nov-2020

Description

Summary:

For one of the most successful global players in the pharmaceutical industry DOCS is hiring a Sr. Clinical Trial Lead (m/w/d). If you have experience in and want to develop further into global Clinical Safety Management from a sponsor’s perspective and by doing so, helping to improve treatment of today’s biggest challenges to public health, than this might be for you.

The role of the Sr. Clinical Trial Lead (m/w/d) is to contribute to effective and efficient proactive safety strategies for the assigned processes and delivery of operational safety aspects. This includes the provision of key expertise and guidance to concerned Global Drug Safety functions and other functions within the company, as well as vendors for safety operational tasks.


Key responsibilities:


• Responsible and accountable for planning, coordinating, preparing and conducting complex clinical trials, including the budget within assigned therapeutic area(s)

• Collaborates in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards and services

• Uses specialist knowledge, advanced analytical skills, judgement, broad conceptual and practical experience to solve complex problems and contribute to process improvements

• Has in‐depth business knowledge and strategic understanding of how cross‐functional teams jointly achieve objectives and goals of trial team, utilizing knowledge of the organization, processes, customers and key business drivers to increase effectiveness

• Effective leader, ability to identify and resolve technical, operational and organizational problems with high complexity

• Filters, prioritizes, analyzes, and validates information from a diverse range of external and internal sources to respond to operational challenges

• Acts as functional lead for process improvement initiatives

• Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations

• As a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals and objectives of the Clinical Operations Team and/or Global Program Team

• May in addition take leadership of the Clinical Operations Team

• Drives protocol development process. Provides clinical, scientific and operational input into concept sheets and protocol (rational, objectives, design), Case Report Form, and other key protocol/program documents and activities

• Leads multiple cross‐functional trial teams through start‐up activities including study/site budgets and
contracts, global geographic deployment (country/site identification, feasibility, selection), and country/site protocol approvals (MOH, IRB/EC) to study conduct, analysis and reporting

• Leads the execution of clinical phases of assigned global programs across all phases (Phase 1‐4) including post‐marketing commitments and Biosimilars

• Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution

• Drives oversight of CROs and vendor management at trial level according to the applicable partnership model

• Understanding of trial feasibility elements

• Understanding of regulatory requirements across countries

Education & Experience

• Advanced degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) preferred or equivalent
• Requires a graduate degree (or equivalent) that provides knowledge of theories, principles and concepts within the discipline
• Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development Process


Conditions:

• Permanent Contract
• Full time, ideally office based in Frankfurt/Main area. Home office options can be discussed
• Great pipeline of studies
• Top 4 global player in the pharmaceutical industry
• Contribution to pension scheme


Why this vacancy is right for you:

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Interested? Please submit your CV to Roger.BravoMendez@docsglobal.com or via our homepage www.docsglobal.com. We are looking forward to your application.