南京招聘

DESIGNATION:

Clinical Monitor Local (Associate Project Manager)

DEPARTMENT:

Clinical Research

REPORTING RELATIONSHIP:

Report directly to Head Clinical Research with extensive

interaction with other functional lines in China OPU, Regional Office and Global Teams

PRIMARY RESPONSIBILITIES

Coordination and management of local and international studies for China with collaboration and support from other departments. Actively contribute to the development of BI clinical reearch knowledge in China including healthcare system, regulatory requirements, site capabiities, ect. Provide reports on global/local trial activities in China and progress updates/changes on global development programs to appropriate stakeholders in a timely manner. Adherence to SOPS in planning, conduct and reporting of clinical trials.

Accountabilities

The major role of CML is to manage clinical trials locally and the main responsibility of the CML lies in the project management.

· Adherence to SOPs in the planning, conducting and reporting of clinical trials.

· Calculate timelines and resources for local (CTMS) use.

· Calculate study budget and prepare contracts with investigators.

· Consult colleagues on country-specific issues in protocol writing.

· Produce Informed Consent for local use and the local level Investigator Site File (ISF).

· Prepare investigator and site profile for investigator selection.

· Manage local clinical study progress and report to RPM for multi-national clinical trials.

· Manage local Project Teams and ensure that local standards are in harmony with agreed international standards.

· Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and current issues. Records of training should be maintained.

· Contact with CTSU regarding design of country-specific labelling, packaging and drug logistics.

· Ensure timely submission to Independent Ethics Committee (IEC) and support investigator as necessary.

· Review CRA monitoring report and provide feedback as necessary.

· In conjunction with DMU, participate in regular Data Quality Review Meetings (DQRMs).

· Ensure SAEs are reported in line with GCP and SOP.

· The CML has the final responsibility in the data clarification and correction process.

· For RDC studies, ensure the completion of RDC evaluation of all sites and set RDC data in CTMS.

· Select CRO for OPU level outsourcing and complete the review of draft agreement for final approval.

· Responsible for CRA performance evaluation or provide feedback to Clinical Research

· Manager, if applicable.

· Organize OPU level investigator meeting.

QUALIFICATION

1) Qualification Criteria

· Min 3 years experience in all aspects of clinical monitoring as a CRA

· Shows good leadership qualities & excellent communication skills

· Good organization & planning skills

· Fluent in English

· Good knowledge of GCP / Monitoring Clinical Trials / Trial management

· Achieve good quality and recruitment

· All pre-requisition for CRA must be met

2) Assessment to be promoted to Clinical Monitor Local

· Recommendation by local CRM and approved by LMD

· Assessment Checklist to be completed by local line manager to document the qualities for promotion

· Training + Assessment

· Qualification + Certification

3) Training

- Basic Training

· Basic CRA / CML (including Leadership and CRO management) Training with Certificates

· Trial auditing/ inspection

· Certificate + Training Logs provided as documentation

- Elective Training

· Management skill