Beschreibung
Aufgaben:- Finalizing Data Transfer Agreements with ECG provider, lab, PK, e-diary and overview the first transfers from these providers (according to specified structure, according to timelines?)
- Setup of QC plan for internal overview of the data and perform QC
- Review performance of CDM CRO, e-diary provider and sites in regard of timelines and quality (e.g. quality of queries, answers, performance of eCRF, shipment of devices, compliance with e-diary, turnaround times e.g. of data entry)
- Initiation of medical review process, review of quality of science's queries, interface between science and DM CRO
- Initiation of coding process, review of DM CRO's quality of coding medical history and medication
- Coding of AEs internally, interface to Drug Safety for coding approval
- SAE reconciliation
- Implement process to receive PK raw data (concentrations in a blinded manner) before DBL into CDW
- Adapt protocol deviation process where necessary (here there is always a high frequency of adaption to "real life" needed)
- Be the interface between the study team to BM in regard of planning receipt of SDTM data and organize meetings accordingly
- Check, approval and tracking of monthly invoices from our contractors
- Day-to-day business, e.g. feedback on several questions / requests from science, operations, investigators, study nurses, Drug Safety, PK department, CRAs and BM internally (e.g. ongoing update of status report layout, medical review listings, frequency of delivery of documents, explanation about queries to the sites / CRAs etc.)
Vertragsdetails:
Start: 02.01.2014
Laufzeit: 3 Monate, Verlängerung möglich
Stundensatz: max. 50€ (Urlaubs- und Krankheitsausfälle werden wie in einer Festanstellung bezahlt)
Ich freue mich auf Ihren CV!
Herzliche Grüße,