Clinical Study Manager- Oncology

IQVIA • Durham, NC

2d • $93,100 - $232,800

About The Position

The Clinical Study Manager, referred to in the posting as a Clinical Lead, is an integral member of the core project team and is responsible for clinical delivery of assigned studies in accordance with contractual requirements, regulatory requirements, and applicable SOPs, policies, and practices. The role leads clinical teams and partners with Project Leaders and other functional teams to ensure that projects meet delivery requirements and support the timely development of new drugs.

The Clinical Lead oversees recruitment, clinical risk management, quality, project finances, stakeholder communication, milestones, resourcing, and talent planning throughout the project lifecycle. The role establishes operational plans and provides project-related training and guidance to clinical teams. It may also involve supporting proposals and bid defenses, mentoring peers, working alongside other Clinical Leads on large global trials, and attending site visits as needed.

Requirements

• Bachelor’s degree in health care or another scientific discipline.
• At least 5 years of clinical research or monitoring experience, or an equivalent combination of education, training, and experience.
• Basic knowledge of project management practices and terminology.
• Good knowledge of applicable clinical research regulatory requirements, including GCP and ICH guidelines.
• Broad protocol and therapeutic knowledge.
• Good understanding of the clinical research industry and the environments in which it operates.
• Understanding of project finances.
• Knowledge of clinical trial conduct and the application of ICH, GCP, and relevant local laws, regulations, and guidelines.
• Strong written and verbal communication skills, including good command of English.
• Problem-solving skills.
• Planning, time management, and prioritization skills, including the ability to manage conflicting priorities.
• Attention to detail and accuracy, with a results-oriented approach to work delivery.
• Influencing, negotiation, judgment, and decision-making skills, as well as mentoring and training skills.
• Good software and computer skills, including Microsoft Word, Excel, and PowerPoint.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Ability to work across geographies with awareness and understanding of cultural differences.
• Ability to influence without authority.
• Ability to demonstrate IQVIA Core Competencies: Client Focus, Collaboration, Communication, Innovation, and Ownership.

Responsibilities

• Ensure clinical delivery of assigned projects in compliance with regulatory, customer, and internal requirements.
• Be accountable for project recruitment targets and ensure appropriate recruitment strategies are in place.
• Contribute to the project risk mitigation plan and manage clinical risks throughout the project lifecycle.
• Identify clinical quality requirements, plan how compliance will be measured, and monitor and oversee clinical quality issues.
• Manage clinical aspects of project finances, including Estimate at Completion (EAC); create delivery plans, monitor changes against the baseline, and identify additional service opportunities or out-of-scope work.
• Identify and manage internal and external project stakeholders through effective communication and resolution management.
• Collaborate with the clinical team to support milestone achievements and report to stakeholders in accordance with project scope requirements.
• Plan clinical team resourcing and talent, and manage the team through operational plans, guidance, and project-related training.
• Conduct regular team meetings and communicate appropriately to achieve objectives.
• Provide clinical team line managers with feedback on team members’ performance relative to project tasks.
• Potentially contribute to clinical delivery strategies for proposals, participate in bid defense preparations and meetings, and develop and present Clinical Operations plans with Business Development and Project Leadership.
• Potentially mentor and coach peers who are new to the role.
• Potentially serve as a primary Clinical Lead alongside other Clinical Leads on large global trials.
• Potentially attend site visits in support of project delivery.

Benefits

• The posting states that, depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager