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Job Description
This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance and regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Responsibilities include, but are not limited to:
Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance ofdeliverables/timelines/resultsto meet country commitments from feasibility and site selection, recruitment, execution and close out.
Reviews Monitoring Visits Reports and escalates performance issues and training needs. - Performs Quality control visits as required
Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
Responsible for creating and executing a local risk management plan for assigned studies
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
Country POC for programmatically outsourced trials for assigned protocols.
Serves local business needs as applicable in his/her country(If delegated can sign contracts and manage budgets)
Collaborates internally with HQ functions and locally with pharmacovigilance and to align on key decisions in his/her studies.
As a customer-facing role, this position will build business relationships and represent our company with investigators
Shares protocol-specific information and best practices across countries\clusters
CORE Competency Expectations:
Knowledge in Project/Site Management.
Strong organizational skills with demonstrated success required.
Requires ability to make decisions independently and oversee important activities
relevant to clinical research activities according to predetermined global policies and
Requires strong understanding of local regulatory environment
Strong scientific and clinical research knowledge is required
Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication. Strategic thinking
Behavioural Competency Expectations:
Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our company Research Labs, Global Clinical Development and our Research & Development division.
Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
Required to negotiate skilfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations
Educational/pedagogic,diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders
Experience Requirements:
Required:
5-6 years of experience in clinical research of which 3 as monitor
Educational Requirements:
Required:
Bachelor degree in Science (or comparable) .
Preferred:
Advanced degree, (e.g., Master degree, MD, PhD
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
Job Posting End Date:10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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