Country Lead Monitor (CLM)

[Your tasks and responsibilities]

1. STUDY/COUNTRY: The CLM is the key country study contact for the core study team and overall responsible for country deliverables regarding timelines, budget and quality for assigned studies from feasibility all the way through archiving.
a. The CLM develops the country enrollment and retention plan, manages country site selection and initiation, country risk leveling, patient enrollment and data cleaning activities.
b. Further, develops contingency plans, ensures ethical, regulatory and SOP compliance necessary to provide quality data required for global regulatory submissions for drug approval.
c. The CLM is the leader of the local study team, and also the main contact across other functions locally.
d. The CLM ensures that the CRA team receives study specific training, identifies training gaps and develops further training plans in liaison with the core study team as required.
e. The CLM tracks overall country study progress to meet the country deliverables, and develops and manages mitigation planning.

2. STUDY/COUNTRY:  The CLM may be assigned to be the primary liaison for CRO and ARO-run studies. For the CRO and ARO liaison role, a CLM will be responsible to align the relevant stakeholders internally and externally, to support regulatory and country start-up activities and to coordinate quality initiatives.

3. START UP:
a. The CLM manages all feasibility activities and provides credible country feedback. In specific countries, the CLM could be assigned to oversee feasibility activities across all studies
b. Upon country confirmation, the CLM oversees all country startup activities and contributes to completion of all necessary study documents for ethics and regulatory approval for site initiation according to agreed timelines. The CLM ensures all legal, regulatory and Bayer requirements are met prior to site initiation.

4. QUALITY: The CLM is responsible for the overall quality of the study in his/her country by using relevant IT systems, among other tools.
a. The CLM proactively identifies potential or actual country related issues that may impact the quality and compliance of the data, provides appropriate solutions and ensures actions are implemented. The CLM is responsible for country level corrective action / preventive action plans (CAPAs) maintenance.
b. The CLM oversees country  TMF completeness and quality, ensuring that quality checks are performed and appropriate actions are in place to ensure files are ready for Inspection and are filed in accordance with relevant SOPs, ICH GCP and regulatory  guidelines
c. As a member of the audit/regulatory inspection team, the CLM is a key contributor to the preparation, conduct and follow up of site audits and regulatory inspections to ensure a successful outcome.
d. The CLM performs monitoring report review and ensures follow up items are resolved  according to SOPs / OI. The CLM regularly conducts co-monitoring visits to ensure the quality of the study

5. OVERSIGHT: Due to experience and expertise, the CLM may act as a mentor for new or less experienced CRAs and CLMs.  The CLM may be assigned to specific local and global expert working groups, roles, initiatives or other activities at the discretion of the CHSM.

6. COLLABORATION: The CLM establishes proper collaboration with local functions such as medical affairs, pharmacovigilance, regulatory, legal, compliance to ensure the study is conducted in accordance to local requirements and regulation.

7. BUDGET: The CLM is accountable for planning, managing and tracking local study budget in close liaison with the assigned CTPS specialist as well as the core study team. The CLM identifies budget/estimate issues and proactively develops a plan until resolution

[Qualifications / Requirement]

-  The incumbent must have a Undergraduate degree’ (or equivalent) with 5 years of relevant healthcare experience including 4 years monitoring & site management experience or 2 years of clinical trial management experience.
- Deep knowledge of R&D processes and local &global regulations
- Project management skills
- Decision-making and issue resolution skills
- Cross-Functional collaboration
- Budget management
- Effective written and verbal English communication skills