Clinical Team Leader will be responsible for overseeing the monitoring and site management activities on assigned clinical research projects as per business needs.
- Expert theoretical and practical knowledge of ICH-GXPs requirements applicable to Clinical Operations and ability to train others in all those guidelines
- Expert knowledge of and compliance with relevant international and local regulatory requirements
- Conversant with and completely equipped to handle all activities as listed below but not limited to
- Accurate identification of SAEs (if applicable), with appropriate follow up action and documentation
- Identifies potential study problems, implements solutions, follows through to resolution and improves timelines. Proper and timely escalation of issues.
- Demonstrates ability to assist CPM and team with projecting timelines and achieve project deliverables.
- Demonstrate ability to assist CPM by contributing in Co-Monitoring & detailed review and/or finalization of trip visit reports and follow-up letters within timelines – as delegated by CPM.
- Assist CPM in keeping track of trip visit frequency and its timely reporting by tracking monitor’s schedule per project monitoring plan (if applicable) on on-going basis.
- Demonstrate proficiency in conducting all visit types, including accompanied visits for training/mentoring purposes.
- Excellent communication skills, including effective and appropriate interaction with the study team, site staff, other KLINERA departments, senior management (director level and above) and any external parties involved (sponsors, vendors and other third parties).
- Ability to facilitate team building, conflict resolution and negotiation as needed to promote productivity and the accomplishment of timelines.
- Ensure quality maintenance of study related files (both electronically and hardcopy)
- Successfully handle complex issues, including appropriate prioritization of competing tasks/assignments for self and team members with minimal input from manager
- Excellent training and mentoring skills (including constructive feedback)
- Active participation in client meetings/teleconferences/general communications. Ability to participate in bid defence meetings if applicable.
- Development of high quality study-related documents, including, but not limited to, study-specific processes, newsletters, team training materials, and study status reports for client meetings
- Understanding the management of unit based contracts and profitable staff utilization/recovery according to the units within the contract for clinical services
- Provides effective and timely feedback to the CRA team as appropriate
- Effective negotiation of (or oversight of) Investigator site contracts and budgets, where applicable
- Actively participates in site payment runs and basic understanding regarding data input into tracking systems and analysis of site payments with supervision
- Initiates Risk and Contingency Plans before risks arise and implements plans/triggers appropriately
- Has demonstrated the ability to manage multi-service and/or cross-functional medium to large/complex projects in accordance with timelines and budgets
- Ensures designated study team consistently meets the quality standards and metrics requirements for well written trip reports and follow-up letters
- Competency in supervising the set up/maintenance of the study fileto audit standards
- Successfully handle complex issues, including appropriate prioritization of competing tasks/assignments for self and team members
- Demonstrates thorough knowledge of tracking systems including analysis of data output for potential errors and study trends. Accountable for all study and coordination with trial site related activities to the assigned CPM and the sponsor
- Participate in the hiring Clinical Operations personnel interview process and provide feedback as requested.
- Good training and mentoring skills (including constructive feedback) to team members and the ability and willingness to mentor less experienced CRA/ Sr CRA.
- Effectively manages staff through open, timely and regular feedback, Ensures individual and team achievements are appropriately recognized.
- Participates in the hiring process while recruiting Clinical operation Personnel and provide feedback. Ensures staff turnover is minimal by supporting staff recruitment and retention initiatives, as required.
- Participates in local, departmental and company initiatives/activities
- Remain aligned to common organization objectives and individual project deliverables
- Flexible to take up add-on responsibilities & deliver satisfactorily all the tasks assigned by respective line manager/ PM &/or H-GCO in order to support the project deliverables &/or department improvisation.
- Demonstrate and maintain customer focus
REQUIRED EXPERIENCE:-
- Approximately 5-7yr experience as Sr Clinical Research Associate or Associate CTL in CRO/Sponsor companies.
- Fundamental knowledge and good understanding of GCP, clinical study development process, and logistics.
- and consistent attention to detail and follow through on commitments.
- to manage and lead the project team.
- line management experience will be an added advantage.