Experience

ERGOMED

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Clinical Team Manager (CTM)

  • Feb 2019 - Present

  - Leading international CRA teams (Ergomed and external CROs and contractors) in clinical trials (Phase I-IV) from feasibility to close-out; also providing training and mentorship- Ensuring project deliverables are met within timelines, including investigator contract execution for Western and Eastern European countries - Supporting the Project Manager in operational project management tasks, e.g. resourcing, budget control, risk management; Delivering up-to-date status reports directly to sponsors - Negotiations with and management of vendors- Organizing and leading project team meetings- Developing, reviewing and revision of project documents (e.g. monitoring plan)- Line Management of CRAs



Lilly Deutschland GmbH

• Germany
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Site Activation Associate

  • Oct 2014 - Jan 2019

  - Negotiation and timely delivery of clinical trial agreements with fair market value budgets, CDAs, LoIs, and regulatory approvals; tracking in CTMS, reporting, eTMF filing - Negotiation and management of site-specific contract templates and Master Service Agreements with frequently used sites - Acting as Subject Matter Expert and Team Lead - Production and maintenance of contract & budget negotiation guidance documents in collaboration with Legal Dept. and Global Budget and Grants Office- Delivery of regulatory approvals “Green Light” packages (administrative and logistic requirements) for Site Initiation and IMP release



ICON Clinical Research GmbH

• Senior Study Start Up Associate

  • Sep 2011 - Sep 2014

• Investigator Contracts Associate

  • Jul 2010 - Aug 2011

• Senior CRA

  • Sep 2009 - Aug 2010

  Key Achievements:- As Lead CRA:o Supporting the CTM at managing trial activitieso Supervising and training the global CRA team for a clinical trial o Development of trial documentso Review of trip reportso Point of contact for sponsor- As CRA / Senior CRAo Initiation, monitoring and close-out of clinical trial sites according to plan o Preparation for audits and inspectionso Preparation of status reportsKey Skills Gained:- Team leadership, supervising and training skills- Expertise in clinical trial conduct, ICH-GCP and the regulatory environment- Knowledge in various therapeutic areas (Endocrinology, oncology, inflammatory and psychiatric disease)- Communication skills with investigator sites, sponsors, internal customers (e.g. global study teams, DM, external vendors)- Sense of duty and customer orientation- Organizational skills, reliability



ICON Clinical

• Clinical Research Associate

  • Feb 2006 - Aug 2009