Job Overview:

• Provide input into the development of integrated study management plans with the core project team and/or sub-team.
• Accountable for assigned portion 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 project 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 internal stakeholders. Support the project leader to prepare/present project and/or sub-team information proactively to external stakeholders.
• Identify risk (positive and negative) and contingencies and partner with project leader in problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project sub-team members and partner with project leader planning/implementing appropriate corrective and preventative action plans.
• May serve as primary (for small projects) or back-up project contact with customer.
• Lead the efforts of a project sub-team, responsible for managing cross-collaboration of the sub-team to support milestone achievement and to manage issues and obstacles.
• Support the project leader in ensuring the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward in partnership with the senior project leader.
• Identify changes in scope and partner with project leader to manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirementsQualifications:
  • Bachelor’s Degree in Life Sciences or related field required
  • Adequate experience in clinical research/monitoring
  • Requires intermediate level knowledge of principles, theories, and concepts of a job area, 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.