Key Accountabilities:
Manages projects/work streams with moderate complexity, risk, impact and reach typically within Ph II or rollover studies in an outsourced model.
Manages medium-sized global project teams with members also from outside the direct working environment.
Coordinates stakeholders from closely related areas or even beyond.
Demonstrates skills in successfully leading international teams in the matrix
organization and direct, influence and motivate people; contributes to a positive working climate.
Coordinates operational and therapeutic area training for internal and external study team members.
Accountable for successful project execution including definition of milestones. May also include clarification of project scope.
Acts as an advisor and mentor within the team and beyond and may serve as best
practice resource within own discipline or as technical expert on cross functional teams or projects.
Leads the development of the clinical trial strategy and delivers the clinical operational plan within the budget, timelines and quality standards agreed upon by Governance Committees.
Accountable for oversight of CROs in the execution of assigned trials
Represents Global Development Operations (GDO) within the Global Trial Team and serves as the key GDO operational point of contact for the trial.
Accountable for the successful preparation and presentation of operational content at respective governance bodies
Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Operations Team.
Drives and leads the successful execution, oversight and approval of all clinical trial documents and operational plans of global clinical trials using strong project management, leadership, and organizational skills.
Ensures strong oversight, review, and delivery of trial/project CAPAs to meet corporate compliance standards and timelines.
Accountable for partnering with CRO in audit responses and addressing quality issues.
Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the R&D financial standards.
Performs review and provides strong operational input in the development of clinical trial protocols, ICFs and CSRs
Filters, prioritizes, analyzes, and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
Supports the development and implementation of department initiatives including input on SOPs, processes, and workstreams.
Ensures strong inspection readiness application for all assigned clinical trials.
Normally receives little or no instruction on daily work and only general instruction on new assignments
Strategic Impact
Handles, oversees, and prioritizes multiple moderate/complex tasks simultaneously; excellent time management skills; works with minimal supervision; self-directed and proactive.
Can lead up to 2 moderate complexity studies in parallel
May support cross-functional initiative.
Ensures studies are running according to plan and expectations, directs daily operation
of clinical study(ies) to meet expected timelines and achieve milestones while ensuring quality and adhering to budget.
Manages cross-functional teams and vendors to achieve key performance and quality indicators to accomplish company and individual goals.
Presents reports to senior management, including updates on financials, forecasts, and timelines with minimal supervision.
Finds creative solutions to moderate/complex problems and makes suggestions for the improvement of existing processes; quickly modifies behavior and supports others in dealing with changes in the work environment.
Thinks beyond the confines of own function; considers interfaces and pro-actively fosters cross-functional/global approaches.
Proven ability to manage internal and external customers.
Proven ability to anticipate, recognize, and manage issues: Analyzes clinical study and investigative site risks and implements corrective actions, where required.
Proven ability to apply critical thinking skills.
Collaborates with vendors and verifies each is meeting expectations according to scope of work and budget.
Utilizes technology and available sources of data to verify vendors are on target for deliverables in an ongoing manner and strategizes to consolidate and streamline processes.
Scope of responsibilities:
Leads Clinical Trial Team
Demonstrate leadership, promote communication and adequate information flow to align 3 of 4 trial with the strategic objectives.
Assess resource needs and makes recommendations for allocations across the trial(s).
Qualifications:
Minimum of 7 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 4 years of in-depth knowledge and experience in clinical trial management.
Experience in all aspects of clinical study planning and startup (including budget and resource planning) and in executing the complete range of clinical study activities, from startup through final study report.
Requires professional experience in relevant disciplines and substantial project management experience. Requires senior knowledge and experience in own discipline and beyond which may also require good market and competitor knowledge.
Requires professional experience in relevant disciplines and project management experience. Requires knowledge and experience in own discipline and beyond which may also require good market and competitor knowledge.
Leadership competencies and influencing skills.
Effective oral and written communication skills
Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.
Good knowledge of drug development process, interfaces, and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com
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