1.
All aspects of site & project management and monitoring activities for
assigned applicable Phase I and all Phase II-IV clinical Investigator sites
within the approved Clinical Development Plan (CDP).
2.
Managing Investigator site and site activities and monitoring site data, to
ensure patient safety and ethical and regulatory compliance necessary to
provide quality data required for global regulatory submissions for approval
of drugs.
3.
Managing Investigator sites to ensure the Investigator and Site Staff meet
all aspects of study delivery and commitments to make certain the operational
study execution is on track from site selection to site close out.
4.
Rigorous regulatory guidelines exist to ensure overall patient safety related
to reporting of serious or unexpected adverse drug reactions.
5.
Due to the highly regulated clinical trial environment, the CLM proactively
identifies potential issues and develops site Corrective Actions / Preventive
Actions (CAPAs) Plans.
6.
As key contributor to the Trial Master File and study documents at the
country level, ensures essential documents are appropriate and filed in a
timely manner in the Investigator Site File.
7.
Incumbent is a key contributor in the preparation, conduct and follow up of
Site Audits and Regulatory Inspections to ensure a successful outcome. The
CLM is a member of the audit/regulatory inspection team.
8.
Due to experience and expertise, the CLM may be a mentor and role model for
new or less experienced CRAs on process, study, technical or behavioral
competencies.
9.
For outsourced studies: the CLM is the primary contact with the country CRO
team and will support the CRO with regulatory and ethics submissions. The CLM
will keep the Country Medical Director and local MSM teams informed of the
status of the study. In addition, the CLM may conduct co-monitoring visits
with the CRO as detailed in the Study Oversight Plan
10.
Managing the cross-functional Country Feasibility team and process, involving
the local Monitoring and Site Management and local Medical organizations.
11.
Leading cross-functional Site Selection Team to identify and determine
interest and suitability of investigator’s for participation in the assigned
study.
12.
Developing Core Country Study Documents to initiate the study and ensures all
study sites are initiated according to planned study timelines.
13.
Developing the Country Enrollment and Retention Plan. Managing and tracking
country site initiation, enrollment, data cleaning activities to ensure they
are consistent with country commitments and study timelines.
14.
Managing and tracking the Study Country Level Budget, providing monthly
country budget information to Local Controlling, LHMSM and Study Manager, as
well as identifying budget/estimate issues and proactively developing a plan
for resolving study finance issues.
15.
Ensuring all country CRAs are trained sufficiently for the trial.
16.
Overseeing Country Study Oversight Plan to ensure quality and compliance
which may include co-monitoring visits and coordinating Data Verification
Initiatives.
17.
Creating Country Monthly report and proactively notifying SLM and LHMSM of
any potential issues with proposed solutions to ensure country participation
remains consistent with country commitments.
| 
