Sr Site Mgr 1, Real World Evidence

hace 4 semanas

Desde casa, Colombia IQVIA A tiempo completo

**Job Overview**
Responsible for remote site monitoring activities to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

**Essential Functions**
- Serves as an in-house CRA responsible for site management on assigned sites.
- Performs study evaluation, initiation, remote monitoring, and close out visits remotely as appropriate. May monitor and/or co-monitor at sites when needed.
- Collaborates with field CRAs on assigned sites.
- Mentors and provides guidance and training to other in-house CRAs as necessary.
- Serves as a primary contact between IQVIA and the investigative site on assigned sites and ensures proper documentation of site management communications.
- Serves as back-up to assigned field CRAs and/or in-house CRAs
- In collaboration with the assigned field CRA, performs routine site management activities, including site training, assistance with site questions, patient recruitment and retention management, study supplies management, and other activities needed to ensure that assigned sites are conducting the study(ies) as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
- Collaborates with assigned field CRAs to resolve and document outstanding site issues/action items
- reviews the quality and integrity of patient data at assigned sites through the remote review of electronic case report form (CRF) data. Ensures timely transmission of clinical data from assigned study sites and works with sites to resolve data queries
- Assists with final data review and query resolution through database lock. Inclusive of patient profile and data listings review
- Assists with the development of the Integrated/Clinical Data Review Plan for assigned studies
- Assists with the development of patient profile and data listings for review during data cleaning activities
- Assists with the development of risk assessment thresholds and recommended actions for Key Performance Indicators (KPIs) for a study or program
- Makes recommendations about adjustments to KPIs and data analytics reviewed to ensure output continues to be appropriate.
- Designs data analytics to assess risk and works with appropriate functional department/vendor to program the designed reports
- assists with and attends (as needed) Investigator Meetings on assigned studies
- Authorized to request site audits for reasons of validity
- performs other duties as requested by Management.
- May assist in the creation of Risk-Based Quality Management process and documentation plans for data surveillance analyses. Ensure that risk-based quality trial management processes are performed to identify, assess, control, communicate and review study risk.
- May help ensure timely and appropriate site payments and updates the clinical team as required to ensure proper timing and amount of payments.

**Qualifications**
- Degree in scientific discipline or health care (preferred).
- Minimum of 3 years clinical research experience (regulatory and monitoring responsibilities) required.
- Good written and verbal communication skills including good command of English language.
- Good organizational and problem-solving skills.
- Ability to manage multiple priorities within various clinical trials.
- Ability to reason independently to assess and recommend specific solutions in clinical settings.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Ability to understand electronic data capture including basic data processing functions.
- Familiarity with current International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and applicable regulations to the conduct of clinical research.
- Ability to mentor other employees.

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