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Clinical Trial Manager
Eingestellt von Michael Bailey Associates - Zurich
Gesuchte Skills: Support
Projektbeschreibung
WE HAVE A NEW OPPORTUNITY FOR A CLINICAL TRIAL MANAGER TO JOIN VERY BUSY TEAM ON 12 MONTHS CONTRACT TO SUPPORT ALL OPERATIONAL TRIAL DELIVERABLES ACCORDING TO TIMELINES, BUDGET, OPERATIONAL PROCEDURES, QUALITY/COMPLIANCE AND PERFORMANCE STANDARDS.
RESPONSIBILITIES:
-PREPARE CLINICAL OUTSOURCING SPECIFICATIONS AND MANAGEMENT OF CONTRACT RESEARCH ORGANIZATIONS (CROS) TO ENSURE ADHERENCE TO SCOPE OF WORK WITHIN TIMELINES AND BUDGET.
- SUPPORT THE DEVELOPMENT, MANAGEMENT AND TRACKING OF TRIAL BUDGET AS ASSIGNED, WORKING CLOSELY WITH THE APPROPRIATE PARTNERS MANAGE INTERACTIONS WITH RELEVANT LINE FUNCTIONS INCLUDING DATA MANAGEMENT, DRUG SUPPLY MANAGEMENT UNDER THE SUPERVISION.
- ATTEND CLINICAL TRIAL TEAM (CTT) MEETINGS, PARTICIPATE AND REPORT STUDY PROGRESS AND ISSUES/RESOLUTION PLAN AT THE CLINICAL TRIAL TEAM MEETING. RESPONSIBLE FOR ACCURACY OF TRIAL INFORMATION IN ALL TRIAL DATABASES AND TRACKING SYSTEMS. RESPONSIBLE FOR THE ONGOING SCIENTIFIC REVIEW AND VALIDATION OF CLINICAL DATA (MEMBER OF THE DATA REVIEW TEAM).
- PARTICIPATE IN THE ORGANIZATION AND LOGISTICS OF VARIOUS TRIAL-RELATED COMMITTEES. POINT OF CONTACT FOR MANAGING SITE-RELATED ISSUES AND PROCEDURAL QUESTIONS. DEVELOPMENT OF CASE REPORT FORMS (CRFS), EDIT CHECKS, CRF COMPLETION GUIDELINES, DATA REVIEW REPORTS AND TRIAL STATISTICAL ANALYSIS. WRITE CTT MEETING MINUTES.
- PREPARE TRAINING MATERIALS AND PRESENTATIONS RELATED TO THE PLANNING AND CONDUCT OF THE TRIAL. CONTRIBUTE TO PROGRAM LEVEL ACTIVITIES (EG, DEVELOPMENT OF CLINICAL SECTIONS OF REGULATORY DOCUMENTS SUCH AS INVESTIGATORS' BROCHURES, DSUR/PSUR, IND/NDA SUBMISSION DOCUMENTS) AND PROVIDE SUPPORT, AS NEEDED, FOR HA AND/OR IRB/IEC INQUIRIES.
CANDIDATE PROFILE:
Degree or equivalent education/degree in life science/healthcare is strongly recommended.
2 to 5 years of experience in clinical development and global clinical research.
Involvement in cross-functional, multicultural and international clinical trial; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
Excellent communication, organization and tracking skills.
Strong operational skills and demonstrated ability to meet timelines.
Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
RESPONSIBILITIES:
-PREPARE CLINICAL OUTSOURCING SPECIFICATIONS AND MANAGEMENT OF CONTRACT RESEARCH ORGANIZATIONS (CROS) TO ENSURE ADHERENCE TO SCOPE OF WORK WITHIN TIMELINES AND BUDGET.
- SUPPORT THE DEVELOPMENT, MANAGEMENT AND TRACKING OF TRIAL BUDGET AS ASSIGNED, WORKING CLOSELY WITH THE APPROPRIATE PARTNERS MANAGE INTERACTIONS WITH RELEVANT LINE FUNCTIONS INCLUDING DATA MANAGEMENT, DRUG SUPPLY MANAGEMENT UNDER THE SUPERVISION.
- ATTEND CLINICAL TRIAL TEAM (CTT) MEETINGS, PARTICIPATE AND REPORT STUDY PROGRESS AND ISSUES/RESOLUTION PLAN AT THE CLINICAL TRIAL TEAM MEETING. RESPONSIBLE FOR ACCURACY OF TRIAL INFORMATION IN ALL TRIAL DATABASES AND TRACKING SYSTEMS. RESPONSIBLE FOR THE ONGOING SCIENTIFIC REVIEW AND VALIDATION OF CLINICAL DATA (MEMBER OF THE DATA REVIEW TEAM).
- PARTICIPATE IN THE ORGANIZATION AND LOGISTICS OF VARIOUS TRIAL-RELATED COMMITTEES. POINT OF CONTACT FOR MANAGING SITE-RELATED ISSUES AND PROCEDURAL QUESTIONS. DEVELOPMENT OF CASE REPORT FORMS (CRFS), EDIT CHECKS, CRF COMPLETION GUIDELINES, DATA REVIEW REPORTS AND TRIAL STATISTICAL ANALYSIS. WRITE CTT MEETING MINUTES.
- PREPARE TRAINING MATERIALS AND PRESENTATIONS RELATED TO THE PLANNING AND CONDUCT OF THE TRIAL. CONTRIBUTE TO PROGRAM LEVEL ACTIVITIES (EG, DEVELOPMENT OF CLINICAL SECTIONS OF REGULATORY DOCUMENTS SUCH AS INVESTIGATORS' BROCHURES, DSUR/PSUR, IND/NDA SUBMISSION DOCUMENTS) AND PROVIDE SUPPORT, AS NEEDED, FOR HA AND/OR IRB/IEC INQUIRIES.
CANDIDATE PROFILE:
Degree or equivalent education/degree in life science/healthcare is strongly recommended.
2 to 5 years of experience in clinical development and global clinical research.
Involvement in cross-functional, multicultural and international clinical trial; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
Excellent communication, organization and tracking skills.
Strong operational skills and demonstrated ability to meet timelines.
Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
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