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our team, you'll have the opportunity to collaborate with talented and
dedicated colleagues while developing and expanding your career.
Project management activities at Global Clinical Trial
Operations (GCTO) are centralized in a regional operations center. At the
Country Operations level, the Clinical Operations Manager (COM) is accountable
for execution and oversight of local operational clinical trial activities and
has ownership, oversight and impact on local regulatory and financial
compliance. The COM reports to the Senior Clinical Operations Manager (Sr. COM).
The COM has a significant impact on how a country can
deliver country:specific trial commitments and objectives especially during
study start:up. The in bent must be able to indirectly influence
investigators, vendors, external and internal partners to deliver these
commitments. This includes addressing and resolving issues, maintaining
expertise in country:based regulations, laws and procedures with minimal
support from the Sr. COM. The position requires skilled knowledge of the
local ethics, legislation and regulatory environment, submission and approval
processes, development of local Informed Consent as well as other site ready
and ongoing study deliverables.
The position requires the ability to proactively develop
risk management and mitigation plans in the country and resolve issues locally.
The COM is accountable for execution and oversight of
operational clinical trial activities in Canada for assigned protocols in
compliance with ICH/GCP and country regulations, Merck policies and procedures,
quality standards and adverse event reporting requirements internally and
and Local Language Materials:
Responsible for execution and oversight of clinical trial
country submissions and approvals for assigned protocols. Oversight of local
language materials including Informed Consents translations and approval. Works
in partnership with IRB/IEC and Regulatory Authority in submission and
approval:related interactions for assigned protocols.
Management and Quality Oversight:
Responsible for managing country deliverables, timelines and
results for assigned protocols to meet
country commitments. Responsible
for quality and compliance in assigned protocols in the country. May oversee
contract workers (CTCs) and local vendors as applicable.
Works in close collaboration internally with GCTO country
operations (CRM, CTC, CRA), CQM, Finance, Medical Affairs, Regulatory Affairs,
PV, Business Compliance, Legal and regional operations, HQ functional areas and
externally with vendors and sites, IRB/IECs and Regulatory Authorities to
ensure country deliverables are obtained for initial and ongoing ethics and
regulatory approval. Collaborates closely with Regional Operations to align
country timelines for assigned protocols. Provides support and oversight to
local vendors as applicable.
Oversight and coordination of local processes. Responsible
for clinical and ancillary supplies management, importing and exporting
requirements, supplies destruction, local electronic/hard copy filing,
archiving and retention requirements, and insurance process management. Enters
and updates country information in clinical, regulatory, safety and finance