Contract - Clinical Research Project Manager

As a Contract Clinical Research Project Manager at StimLabs, your primary responsibilities include managing daily operations of clinical research studies, ensuring compliance with regulations, facilitating communication between the company and investigational sites, overseeing project budgets, and monitoring the collection and analysis of clinical data. You will also be responsible for generating protocol deviation forms, collaborating on clinical study reports, and assisting with peer-reviewed projects.

To qualify for the Contract Clinical Research Project Manager position at StimLabs, candidates must possess a Bachelor’s or advanced degree in a relevant field such as Life Sciences, Pharmacy, or Engineering. Additionally, a minimum of five years of experience in executing clinical research studies or medical product development is required, along with strong project management skills, critical thinking abilities, and proficiency in medical terminology.

The Clinical Research Project Manager at StimLabs is pivotal in supporting regulatory approvals by ensuring that clinical trials are conducted according to applicable regulations and company policies. This role involves maintaining audit readiness, managing compliance activities, and systematically collecting and analyzing clinical data, which are all crucial for regulatory submissions.

To be successful in the Contract Clinical Research Project Manager role at StimLabs, candidates should have at least five years of applicable experience in executing clinical research studies or relevant medical product development and testing. Strong project management skills and experience with budget management are also essential for this position.

The hourly pay for the Clinical Research Project Manager position at StimLabs ranges from $38.50 to $58.50, which reflects the expertise and experience required for this role. This contract position is an excellent opportunity to contribute positively to a growing organization while enjoying competitive compensation.

The most challenging aspect of managing clinical research studies often involves ensuring strict compliance with regulatory requirements and IRB protocols while keeping the project on track. Demonstrating that you can balance these aspects while effectively communicating with all stakeholders is crucial.

Handling budget management for clinical trials requires meticulous attention to detail. I ensure all invoices are accurate and timely and regularly assess budget reports while closely monitoring expenses. Additionally, I communicate any necessary budget adjustments and maintain a clear oversight of accruals to keep the project financially sound.

Effective communication involves setting up regular meetings, using project management tools, and maintaining open channels through emails or internal messaging systems. Keeping everybody informed and actively seeking feedback helps ensure everyone is aligned with project goals and timelines.

To ensure audit readiness, I maintain organized documentation, proactively address any issues that arise during the studies, and ensure all team members are educated about the protocols and compliance requirements necessary for our clinical trials.

When faced with protocol deviations, I follow our established processes to document the deviation accurately, assess its impact, and communicate with the necessary stakeholders. Additionally, I implement corrective actions and work closely with the team to prevent future occurrences.

Monitoring the progress of clinical trials involves tracking key performance indicators such as enrollment rates, data collection timelines, and compliance with protocols. Utilizing project management software helps me keep all elements visible and allows for immediate intervention if we veer off course.

I have significant experience with various clinical research databases and focus on ensuring data integrity throughout the study period. I am well-versed in performing basic statistical analyses to support clinical evidence, which contributes to the overall quality of the project results.

Staying updated with the latest regulations involves attending workshops, webinars, and conferences related to clinical research. Subscribing to industry newsletters and joining professional associations also provide valuable insights and updates, ensuring I remain compliant with changing standards.

Fostering a productive team environment means promoting collaboration, transparency, and open communication. I create an environment where team members feel valued and encouraged to share ideas and concerns, which enhances overall team morale and project success.

If a clinical trial is behind schedule, I would first assess the contributing factors by consulting with team members and analyzing timelines. Based on this insight, I would implement a recovery plan, adjusting resources or timelines as necessary, and ensure continuous communication with all stakeholders to manage expectations.