Assistant Manager for Clinical Operations at Apotex ensuring compliance and management of clinical studies. Overseeing training, documentation, and volunteer safety within clinical settings.
About the role
- Project Lead overseeing the delivery of clinical studies at IQVIA. Engaging cross-functional teams to enhance clinical trial efficacy within set budgets and timelines.
Responsibilities
- Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
- May be responsible for delivery and management of smaller, less complex, regional studies.
- Develop integrated study management plans with the core project team.
- Accountable for the execution of clinical studies, or assigned portion of clinical studies, per 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 and/or sub-team(s) 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 and/or sub-team information proactively to stakeholders internally and externally.
- 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 and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
- May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as 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.
- Forecast and identify opportunities to accelerate activities to bring revenue forward.
- Identify changes in scope and manage change control process as necessary.
- Identify lessons learned and implement best practices.
- Adopt corporate initiatives and changes and serve as a change advocate when necessary.
Requirements
- Bachelor's Degree Life sciences or related field
- 10+ years of overall clinical trial experience and 7+ year of prior relevant experience including 2+ years of project management experience or equivalent combination of education, training and experience.
- Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience.
- Knowledge of clinical trials - 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. Broad protocol knowledge; therapeutic knowledge desired.
- Strong written and verbal communication skills including good command of English language. Strong presentation skills.
- Strong problem solving skills.
- Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
- Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others.
- Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
- Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
Benefits
- Health insurance
- Flexible time off
- Paid parental leave
- Professional development opportunities
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