Vakante Jobangebote finden Sie unter Projekte.
Global Study Associate Job
Eingestellt von Yoh
Gesuchte Skills: Support, Affiliate
Projektbeschreibung
What You'll Be Doing:
- Provides logistical support to one or more global study management teams (SMT)
- Develops and maintains effective working relationships with SMT members, affiliate team members, and vendors.
- Assists GSM with effective communication between the SMT and Affiliates.
- Coordinates the management of all global drug supply utilizing the designated systems in collaboration with the GSM.
- Tracks and manages the ordering and distribution of non-clinical supplies throughout the course of the study.
- Coordinates investigator and study coordinator meetings in collaboration with the GSL and GSM.
- Tracks and Maintains Study Information and Documentation and Reports on Study Progress Maintains accurate tracking and reporting of Study Management data.
- Oversees the timely tracking of Health Authority/IRB/IEC submissions and approvals in AIMS/CTMS.
- Identifies any delays and raises issues to the GSM and appropriate CSM.
- Provides IRB/IEC and HA submission documentation and all other supplementary documentation to affiliates or PDR as appropriate.
- Assists in the coordination of activities to ensure CRO and vendor delivery against the contracted scope of work
- Participates in the review of vendor study specific scope of work, guidance documents, and manuals in collaboration with the GSL and GSM.
- Organizes the logistics of the vendor kick off meetings and any subsequent face to face meetings in collaboration with the GSL and GSM.
- Participates as required in vendor meetings.
- Coordinates communication for defined tasks and tracking information between the study team and vendor.
- TMF Management Maintains and ensures the completeness of the Study Level Trial Master File (TMF) in accordance with SOP requirements.
- Identifies and contributes to areas of best practice and process improvements
- Proactively incorporates leanings and recommendations from other study debriefs and best practices.
What You Need to Bring to the Table:
- Bachelor's degree with ideally a minimum of two (2) years of experience in a clinical research or health care related industry, or equivalent combination of education and experience.
- Life sciences degree or nursing equivalent is preferred.
- Knowledge of ICH/GCP
- Experience of working as part of large team with a proven ability to make an active contribution to the team's performance and team working.
- Proven effectiveness with written and verbal communication skills.
- Proficient computer skills across multiple applications
- Prioritizes and multitasks to ensure that tasks are completed on time
- Self-motivated and displays initiative (resourceful) - for instance to move actions forward without the need for continual supervision
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Krista Leach
Yoh, a DayJ2W: CLINICAL
MONJOB J2WSWSCI
Ref:
SFSF: LS
Projektdetails
-
Einsatzort:
South San Francisco, Vereinigte Staaten
-
Projektbeginn:
asap
-
Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
-
Kategorie:
Marketing/Vertrieb, Sonstiges