Executive Director overseeing clinical programs in Early Oncology at AstraZeneca. Leading strategic initiatives and innovations in clinical trial operations with a focus on compliance and quality.
About the role
- Senior Clinical Project Manager managing oncology clinical trials for IQVIA Biotech. Overseeing project delivery while optimizing speed, quality, and costs.
Responsibilities
- Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for, multiple service, multiple country and/or multi regional studies. Understand project strategy and operationalise the agreed upon approach.
- Accountable for the strategic planning and execution of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
- Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
- Responsible for delivery and management of medium to large sized, multiple and full service, multi-regional studies.
- Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
- Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
- Serve as primary project contact with customer and own relationship with the project’s key customer contact(s)
- Communicate/collaborate with IQVIA business development representatives as necessary.
- Build the cross-functional project team and lead their efforts, responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.
- Ensure the financial success of the project.
- Identify changes in scope and manage change control process, as necessary.
Requirements
- Bachelor's Degree in Life sciences or related field
- Requires more than 7 years clinical research experience including at least 3 years project management experience.
- Requires greater than 2 years of experience managing Global studies.
- Therapeutic area knowledge in Oncology is a must.
- Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
- Strong written and verbal communication skills including very good command of English language.
- Requires strong negotiation and customer management skills.
- Excellent customer service skills and demonstrated ability to understand customer needs.
- Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
- Ability to work across geographies displaying high awareness and understanding of cultural differences.
- May require occasional travel within Europe and the United States.
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Global team events
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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