Clinical Project Manager, Sponsor Dedicated

About the role

This sponsor-dedicated role provides country-level oversight of clinical trials from study start-up through database lock and closeout. Operating in a fast-paced environment with evolving priorities, the role ensures high-quality data delivery and regulatory compliance across all phases of the trial.

Responsibilities

• Provide input in to 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.
• Strong site engagement qualifications – able to interact with and drive change to address out of compliance sites.
• 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.
• Work with monitors to address systemic site issues.
• 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 requirements.

Qualifications

• Bachelor's Degree In life sciences or related field required
• 3 years clinical trial management experience
• 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.
• Communication - Strong written and verbal communication and ability to facilitate information sharing amongst stakeholders. Strong presentation skills.
• Problem solving - Strong problem solving skills.
• Proven ability to drive change management and follow through on changes to resolution
• Organization - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Prioritization - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• IT Skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Finances - Good understanding of project financials.

Benefits

The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).

Schedule

You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

Pay

The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).