Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Role-related skills

• Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing skills.
• Able to work within remote teams and independently.
• Proficient in optimally balancing multiple responsibilities of growing scope and complexity in a fast-paced environment.
• Good interpersonal skills.
• Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment.
• Respects confidentiality in terms of PII.
• Proactive, meticulous and precise in delivery of quality work even when under pressure
• Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely manner.
• Flexible with high learning and change agility
• Collaborative, building strong internal and external relationships.
• Knowledge of local regulations, IND/ICH GCP - guidelines.
• Available and willing to travel as job requires
• Proficient in using computer systems and meticulous in attention to detail.

• Communicate the progress and relevant information or raise issues of the study to the appropriate study management team
• Engage in effective written and verbal communication with collaborators outside the organization to ensure successful study execution.
• Accountable for local activities required in set up and for high quality execution of studies; will seek managerial or other experienced support as appropriate:
• Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out visits.
• Determines the feasibility of the study protocol with reference to study complexity
• Confirms staff availability, suitable clinical facilities, potential for per protocol patient population.
• Shows the capability to follow ICH GCP and Client requirements for clinical research by conducting site visits and monitoring activities to assess adherence to protocol, regulatory requirements, and overall data integrity.
• Works with Client Study staff to carry out a local study / site level risk assessment.
• Delivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face Client trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical study.
• Participate in global investigators and/or supervise meetings as appropriate. Facilitates
• investigator's participation in global meetings and/or may assist the Client study staff with organizing local investigator meetings. Participates in other study meetings as required.
• Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related achievements are met.
• Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP).
• Work with the sites to ensure they address data queries in a timely manner. Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time.
• Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.
• Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to GCSP and other relevant departments, within the required time frames.
• Completes monitoring visit reports within the agreed timelines.
• Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track).
• Ensure all vital study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately.
• Ensure sponsor study records are inspection ready at all times and archives records as applicable.