Associate Director - Clinical Operations - JN-122021-4552121

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Biopharmaceutical company with focus on innovative rare disease pipeline
Opportunity to make a significant Impact on a small-mid size company

About Our Client

US headquartered pharmaceutical company with innovative development pipeline for rare immunological and neurological diseases

Job Description

Full responsibilities for studies led by the Japan Study Team. * Responsibilities in the global study is complied with Affiliate Involvement Model (AIM), Job aid and direction given by Global Clinical Trial Manager (CTM).
Responsibilities involve a combination of execution and oversight-dependent on the sourcing model - to ensure deliverables and may include, but are not limited to, the following:
Strong understanding of the cost drivers, attuned to principles of cost disciplined science and are able to proactively manage the study budget
Takes ownership and accountability for the development/management/reconciliation of overall study budget(s)
Development/management of vendor scope of work (SOW) per contract, quality, and budget
Review/approval of vendor invoices and management of accruals and SOW changes
Review/approval of site invoices and management of site budget
Drive study execution
Oversight of clinical monitoring quality and adherence to established processes and plans
Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make robust data driven decisions
Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs.
Maintenance/updating of data as appropriate in project management tools including CTMS
Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation

The Successful Applicant

Clinical trial project management skills
Financial budgeting and forecasting skills
Leadership / influence management skills
In depth knowledge of ICH/GCP, JGCP, regulatory guidelines/directives, and drug development and clinical research processes
Ability to effectively lead a cross-functional team in a matrix environmen
Time management skills - ability to effectively multi-task and prioritize
Proven problem solving and decision making skills
Demonstrated success in using oral and written communication skills to influence, inform, or guide others
Disease / therapeutic knowledge
Solid computer skills - requirement of MS applications including (but not limited to),Word, Excel
Study Tools including electronic system skills - CTMS / EDC
Creates realistic plans that clearly define goals, milestones, responsibilities and results
Maintains focus on strategic objectives while accomplishing operational goals
Places a priority on getting results with an emphasis on high quality outcomes
Holds self and others accountable for accomplishing goals
Makes timely, data-driven decisions
Develops and maintains effective working relationships with people across cultures
Encourages collaboration across teams, functions, and geographies
Ensures that conflict is handled constructively so that performance is not impacted
Displays a willingness to challenge the status quo and take risks
Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute
Maintains optimism and composure in times of change, uncertainty, or stress

What's on Offer

Work across rich development pipeline
Highly competitive remuneration package
Global career development opportunities
Flexible working arrangements (WFH options available)
Opportunity to make a significant impact on a small-mid size company
Contribute to development of innovative new drugs in areas of unmet medical needs

Contact

Ed Marsden

Quote job ref

JN-122021-4552121

Phone number

+813 6832 8981