Senior Manager, Clinical Operations

As the Senior Manager, Clinical Operations at Nuvalent, you will lead multiple clinical studies, oversee site selection and contract negotiations, manage budgets, and ensure compliance with regulatory standards. You'll also play a crucial role in team leadership, mentoring junior members, and collaborating with various stakeholders to ensure the success of clinical trials.

For the Senior Manager, Clinical Operations role at Nuvalent, candidates should have a Bachelor’s degree in a scientific or healthcare discipline and at least 5-7 years of clinical operations experience. Extensive knowledge of ICH-GCP guidelines and experience managing oncology Phase 3 clinical trials are also preferred to ensure success in this position.

Nuvalent is committed to professional development and growth. In the role of Senior Manager, Clinical Operations, you'll have opportunities to mentor junior team members and participate in departmental initiatives that support both personal and organizational growth, fostering a culture of continuous learning.

An ideal candidate for the Senior Manager, Clinical Operations position at Nuvalent will be detail-oriented with excellent project management skills. They should possess strong communication abilities, flexibility in handling changing priorities, and the capability to thrive in a remote work environment. Leadership experience and a proactive approach to problem-solving will also be key to success.

The work environment at Nuvalent for the Senior Manager, Clinical Operations is collaborative and innovative, balancing both in-office and remote work options. You'll work alongside experienced professionals in an early-stage company atmosphere that encourages open communication and teamwork to drive impactful clinical research.

In managing multiple clinical trials, I prioritize strong project management and organizational skills. I create detailed timelines, ensure constant communication with team members, and utilize project management tools to track progress. Flexibility in adapting to changing priorities while maintaining a focus on the end goals is also essential.

Absolutely! One of the most challenging trials involved significant budget constraints. I proactively engaged with team members to identify areas for cost-saving without compromising quality, established strong vendor relationships for negotiations, and implemented a rigorous risk management plan to ensure we stayed on track while achieving all milestones.

I ensure compliance with regulatory guidelines through rigorous training, maintaining open lines of communication with my team, and conducting regular audits. I stay updated on the latest compliance regulations and proactively address any potential issues by collaborating with regulatory affairs and quality assurance teams.

Effective collaboration comes from establishing a clear communication structure and shared goals. I encourage team members to share insights and updates regularly, create a respectful environment where all voices are heard, and routinely check in on the progress of tasks. Building trust among team members is also vital.

I evaluate CROs and vendors based on established KPIs and regular performance metrics. Conducting frequent meetings to discuss objectives, timelines, and deliverables helps maintain alignment, while performance reviews allow for constructive feedback and adjustments to ensure high-quality outputs.

I address conflicts by facilitating open discussions to understand the perspectives of those involved. I emphasize collaboration and finding common ground while focusing on solutions that prioritize project goals. Maintaining a respectful environment helps team members feel comfortable voicing their concerns.

My experience with early-phase clinical trials includes developing protocols, overseeing site initiation visits, and managing patient recruitment strategies. This has equipped me with in-depth knowledge of the specific challenges and regulations pertinent to conducting successful early-phase trials.

I manage study budgets effectively by creating detailed forecasts at the beginning of each trial and consistently reviewing expenditures against projections. Open communication with finance allows for timely adjustments, while tracking vendor contracts helps prevent unexpected costs from arising.

I mentor junior team members by providing them with realistic responsibilities that challenge their skill sets while offering support and guidance. Regular check-ins, constructive feedback, and facilitating opportunities for professional development are key parts of my mentoring approach.

To ensure timely data collection, I establish clear timelines and milestones at the outset. Regular communication with site staff and data managers is crucial, as is utilizing digital tools to monitor real-time data entry and addressing any site-level issues as they arise.