Clinical Operations Manager, Clinical Project Leader, Senior Manager Clinical Operations

GMBH
Special Task:
? Participation at site and vendor audit
? Core team member in the CAPA management after an internal mock-GCP audit
? Core Team in developing quality management system
? Preparation of two phase 2 Studies in Europe in Hodgkin's lymphoma and peripheral T-cell
lymphoma
? Preparation of one phase 3 Study in North America, Asia and Europe in Biliary Tract Cancer
Main Tasks and Responsibilities:
? Vendor selection, (Request for Proposal, bid defense meeting and selection of vendors,
contracting)
? Assist in protocol writing
? Development of study project plan (MS project)
? Develop informed consent form and other study auxiliary documents
? Supervises the development of study plans (study management plan, medical monitoring plan,
monitoring plan, communication plan, data management plan, statistical analysis plan,
pharmacy manual, etc.)
? Responsible for clinical study planning from the operational perspective including budget,
timelines, insurance, IMP management, labelling of IMP, risk assessments and management,
management of key performance indicators, management of milestones, etc.)
? Database set up (edit checks; user acceptance testing; completion guidelines, etc.)
? Site selection/ feasibility
? Monitoring and influencing CRO performance on an ongoing basis
? Lining up all other vendors needed to execute the program, including budgets
? Participates in the generation and submission of regulatory and other committee documents
for Clinical Trial Applications
? Manages relationship with key contact at the CRO side such as the responsible project
manager and any other key personnel for the conduct of the trial
? Tracks study progress and participates in regular meetings with CROs, investigators, safety
committee members, and other meetings
? Co-auditing of vendors and sites
? CAPA management
? Assist in developing a quality management system
? Supervises investigator initiated studies




In these tasks, I worked closely with other team members such as the Clinical Leader, the Clinical
Project Manager and the CMC Manager, the Regulatory Manager as well as any other function
that is required to do the job.

PHARMACEUTICALS
Special Task:
? Monitoring of two sites in France
? IMP management, as the first study was stopped for two years many IMP vials were lost,
essentially enough vials were left to complete the study
? Core team in developing quality management system
Main Tasks and Responsibilities:
? Vendor selection and management
? CRO management and oversight
? CRA management and monitoring supervision
? Supervise submission to competent authorities and ethic committees
? Revisions and preparation of study plans
? Revision and support in protocol writing
? Preparation of guidelines/ instruction
? Study tool preparation
? Site selection
? IMP management
? Planning and coordination of labelling and relabeling of IMP
? Monitoring & Co-Monitoring
? Overview data entry and query management
? Laboratory sample management and shipping under GLP condition
? Writing reports
? eTMF supervision and set up
? Budgeting
? Weekly reporting of study progress to Aridis management
? Preparing and conducting investigator meetings
? Study staff training

In these tasks I worked closely with the Medical Director, the CMC Manager, the Regulatory Manager
as well as any other function that is required to do the job

HOSPITAL IN BASEL AT 0.5 FTE
Main Tasks and Responsibilities:
? Preparation, conduct and follow up activities of study initiation visits according to ICH GCP
guidelines and the applicable local laws
? Preparation, conduct and follow up activities of regular monitoring visits according to ICH GCP
Guidelines and the applicable local laws
? Preparation, conduct and follow up activities of study close-out visits according to ICH GCP
Guidelines and the applicable local laws
? Writing of monitoring plans

Studies in all phases of the development, including Investigator Initiated Trials
Cardiology, Atrial Fibrillation, Hypertension, etc.
Pneumology, Pulmonal Hypertension, COPD, etc.
Oncology, Solid Tumors
Diverse: Fertility Trials, Multiple Sclerosis, etc.

Main Tasks and Responsibilities:
? Conduct and plan patient study visits
? Further procession of venous blood, sending blood to the specific laboratories
? Organizing trial specific material such as pregnancy test, etc.
? Dispense study medication
? Correspondence with study monitor and sponsors
? Correspondence with ethic committee and health authorities
? Study submission to ethic committee and health authorities
? Write study protocol and create related documents
? Timely submission of study documents to ethic committee and health authorities
? Recruitment of suitable patients in cooperation with the investigator
? SAE and AE reporting to ethic committee and sponsor
? CRF/ eCRF completion
? Follow up on SAE and AE
? Preparation, conduct and follow up activities of study initiation visits

Phase 3 and 4 studies
Indication: COPD, Pulmonal Hypertension, Sleep Apnea, Asthma

Special Task:
? Participation at site and vendor audit
? Core Team in developing quality management system
? Training of a junior CRA
? Development of the quality system (SOP Manager)




Main Tasks and Responsibilities:
? Preparation, conduct and follow up activities of study initiation visits according to ICH GCP
Guidelines and the applicable local laws
? Preparation, conduct and follow up activities of regular Monitoring Visits according to ICH GCP
Guidelines and the applicable local laws
? Preparation, conduct and follow up activities of Study Close-out Visits according to ICH GCP
Guidelines and the applicable local laws
? SAE and AE reporting according to internal SOP and local laws
? Writing of monitoring plans
? Planning and organizing clinical trials within the EU and USA
? -Writing study protocol
? CRF design
? Ordering of study devices
? Creating/ writing all study relevant documents
? Study Submission to relevant authorities
? Responsibility for adherence to study milestones
? Set up and control of study plan (MS Project)
? Organize audits, manage audit follow-up
? Study data preparation and presentation
? Planning, organization and conduct of investigator meeting
? Study data analyzing and interpretation
? Support and coordinate study publication
? Training of study team members internally and externally
? Study budget full responsibility
? Negotiation with external partners/ vendor
? Training of a junior CRA
? Development of the quality system (SOP Manager)
Studies:
Mainly phase 3 and 4, in North America and Europe
Indication: Dental Implants, Bone substitutes

Phase 3 and 4 studies, in Switzerland
Indication: Hypertension and Cardiology Studies, Oncology Studies

Phase 3 and 4 studies, in Switzerland
Indication: Hypertension and Cardiology Studies, Neurology Studies