Life Sciences Business Consultant
(Pharma und Medizintechnik)
Schlagwörter
Skills
Projectmanagement
Clinical Research
Clinical Monitoring
Clinical Research
Clinical Monitoring
Projekthistorie
10/2016
-
bis jetzt
- Working on consulting projects in the LIfe Sciences sector
04/2015
-
09/2016
Consultant Global Life Science (GLS)
(Pharma und Medizintechnik)
- Support of a large portfolio integration project with focus on Clinical Trial Application process
Main responsibilities include:
- Lead the retrieval of the insurance documentation to enable the clinical sponsorship transfer
- Coordinate / support the retrieval of the submission documentation and contracts for the clinical sponsorship transfer across over 65 CPOs worldwide
- Be accountable for the maintenance and data validation of excel lists that are used as a reference within all participating companies and a CRO, to do so:
- Work closely with 78 Clinical Trial Heads (CTHs) on 78 different clinical trials and provide suggestions regarding whether to transfer the clinical trial sponsorship or not based on the feedback from the CTHs
- Be accountable to retrieve and track the information about patient facing questionnaires for overall 78 trials, working closely with lead CTHs and CPOs worldwide
- Presenting weekly updates of the above topics at cross-company forums and in front of sr. management (e.g. Global Heads, Vice Presidents (VPs))
- Be contact person across all three involved companies for the topics mentioned above
- Accountable team member for performing an analysis about the Clinical Trial Regulatory Landscape in Europe in light of the upcoming changes and comparing the regulatory settings to the US regulations as part of an analysis of the Digital Clinical Trial Management Ecosystem in Europe to allow decisions on investment opportunities
Main responsibilities include:
- Lead the retrieval of the insurance documentation to enable the clinical sponsorship transfer
- Coordinate / support the retrieval of the submission documentation and contracts for the clinical sponsorship transfer across over 65 CPOs worldwide
- Be accountable for the maintenance and data validation of excel lists that are used as a reference within all participating companies and a CRO, to do so:
- Work closely with 78 Clinical Trial Heads (CTHs) on 78 different clinical trials and provide suggestions regarding whether to transfer the clinical trial sponsorship or not based on the feedback from the CTHs
- Be accountable to retrieve and track the information about patient facing questionnaires for overall 78 trials, working closely with lead CTHs and CPOs worldwide
- Presenting weekly updates of the above topics at cross-company forums and in front of sr. management (e.g. Global Heads, Vice Presidents (VPs))
- Be contact person across all three involved companies for the topics mentioned above
- Accountable team member for performing an analysis about the Clinical Trial Regulatory Landscape in Europe in light of the upcoming changes and comparing the regulatory settings to the US regulations as part of an analysis of the Digital Clinical Trial Management Ecosystem in Europe to allow decisions on investment opportunities
09/2014
-
04/2015
Consultant
(Internet und Informationstechnologie)
- Provide consulting in the information technology (IT) sector within insurance companies
- Together with Subject Matter Experts (SME) support the definition of insurance products in a new software
- Set-up the implementation of the products in the new software
- Together with Subject Matter Experts (SME) support the definition of insurance products in a new software
- Set-up the implementation of the products in the new software
02/2014
-
09/2014
Consultant Medical & Science
(Pharma und Medizintechnik)
- Be part of the Project Management Office at a pharmaceutical company to prepare different marketing strategies based on the outcome of a global CV outcome trial
- Support the writing of scientific articles to be published in medical journals including literature research
- Represent Sciarc at large, global medical congresses
- Support the writing of scientific articles to be published in medical journals including literature research
- Represent Sciarc at large, global medical congresses
09/2011
-
10/2013
Clinical Research Associate
(Pharma und Medizintechnik)
- Site-Management of high enrolling investigational sites in London and Germany
- Conduct of initiation, monitoring and close-out visits according to ICH-GCP, Declaration of Helsinki, ISO:2011
- Point of first contact for KOLs and when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials
- Participate in global conference calls and meetings to review progress of ongoing clinical trials, participate in global CV congresses
- Tracking and monitoring of completed electronic Case Report Forms (eCRFs), ensure that queries generated during cleaning are responded to in a timely fashion
- Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment
- Participate in departmental planning sessions, and Standard Operating Procedure (SOP) development
- Provide management to the clinical research assistants to ensure that their role and contribution is optimized
- Conduct of initiation, monitoring and close-out visits according to ICH-GCP, Declaration of Helsinki, ISO:2011
- Point of first contact for KOLs and when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials
- Participate in global conference calls and meetings to review progress of ongoing clinical trials, participate in global CV congresses
- Tracking and monitoring of completed electronic Case Report Forms (eCRFs), ensure that queries generated during cleaning are responded to in a timely fashion
- Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment
- Participate in departmental planning sessions, and Standard Operating Procedure (SOP) development
- Provide management to the clinical research assistants to ensure that their role and contribution is optimized
Reisebereitschaft
Verfügbar in den Ländern
Deutschland
Remote Projekte bevorzugt
