Team Lead (line managemnt): CRAs, Trials CRAs, Trial Manager (local).
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- 22.04.2023
Kurzvorstellung
Working in clinical research (oncology) as CRA, Lead CRA, Trial CRA, Trial Manager (local), Clinical Trial Head (global), Team Lead (line managemnt): CRAs, Trials CRAs, Trial Manager (local).
Qualifikationen
Weitere Kenntnisse
01/2012 – Clinical Trial Head , Oncology, Pharma Company
Global leadership of international clinical trials
Phase I/II/III
Some key points of my work:study protocol writing, lead of clinical trial team, obtain
approval of internal review boards, lead of investigator meetings, contribute to
advisory bords, lead the medical clinical trial data review, lead of interaction with
drug supply, vendors, datamanagement, statistic, medical writer, budget management
01/2011 – 12/2011 Clinical Trial Manager, Oncology, Pharma Company
Regional (Germany) leadership of clinical trials
Phase I/II/III
12/2007 – 12/2010 Lead CRA, Oncology, Pharma Company
Responsible for management of CRA teams
Award for outstanding performance/medical excellence
Sharing Best Practice Award – Kategorie “Team”
Recruitment Excellence Award
Phase I/III
Some key points of my work: Planning/conduct of clinical trials (in-
house+outsourced trials). Management of: budgets, contracts, timelines,
co-monitoring. Communication to: sites/KOLs, CROs, international teams,
cross functional teams. Trainings: CRAs/sites, review: protocol/CRF/SOP.
Preparation of investigator meetings. Participation: internal/external Audits
02/2007 – 12/2007 CRA (Clinical Research Associate), Oncology, Pharma Company
Responsible for site management
Phase III
Global leadership of international clinical trials
Phase I/II/III
Some key points of my work:study protocol writing, lead of clinical trial team, obtain
approval of internal review boards, lead of investigator meetings, contribute to
advisory bords, lead the medical clinical trial data review, lead of interaction with
drug supply, vendors, datamanagement, statistic, medical writer, budget management
01/2011 – 12/2011 Clinical Trial Manager, Oncology, Pharma Company
Regional (Germany) leadership of clinical trials
Phase I/II/III
12/2007 – 12/2010 Lead CRA, Oncology, Pharma Company
Responsible for management of CRA teams
Award for outstanding performance/medical excellence
Sharing Best Practice Award – Kategorie “Team”
Recruitment Excellence Award
Phase I/III
Some key points of my work: Planning/conduct of clinical trials (in-
house+outsourced trials). Management of: budgets, contracts, timelines,
co-monitoring. Communication to: sites/KOLs, CROs, international teams,
cross functional teams. Trainings: CRAs/sites, review: protocol/CRF/SOP.
Preparation of investigator meetings. Participation: internal/external Audits
02/2007 – 12/2007 CRA (Clinical Research Associate), Oncology, Pharma Company
Responsible for site management
Phase III
Persönliche Daten
Sprache
- Deutsch (Muttersprache)
- Englisch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
- Europäische Union
Home-Office
bevorzugt
Profilaufrufe
1016
Alter
52
Berufserfahrung
17 Jahre und 10 Monate
(seit 02/2007)
Projektleitung
5 Jahre
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