Clinical Trials Manager – Drug Delivery Systems – Raleigh-Durham, NC

Are you an experienced clinical trials professional with a passion for advancing drug delivery systems? We are seeking a Clinical Trials Manager to lead the planning, execution, and oversight of clinical trials in the Raleigh-Durham, NC area. This is an exceptional opportunity to work with cutting-edge drug delivery technologies and contribute to the development of life-changing treatments. If you have a strong background in clinical trials management, regulatory knowledge, and a drive for innovation, this role could be the next step in your career.

Lead Clinical Trials for Groundbreaking Drug Delivery Systems

Join a leading organization in the pharmaceutical industry as a Clinical Trials Manager in Raleigh-Durham, NC. The ideal candidate will bring a wealth of experience in managing complex clinical trials, particularly in the area of drug delivery systems. You will be responsible for overseeing trial execution, managing cross-functional teams, ensuring compliance with regulatory standards, and delivering high-quality results on time. If you are committed to making a significant impact in the field of drug development, this is your chance to be part of a groundbreaking team.

Key Responsibilities of the Clinical Trials Manager – Drug Delivery Systems

Clinical Trial Planning & Execution: Lead the planning, design, and execution of clinical trials for drug delivery systems, ensuring alignment with regulatory requirements and company objectives. Collaborate with cross-functional teams to create comprehensive trial protocols and ensure all milestones are met on time and within budget.

Regulatory Compliance & Quality Assurance: Oversee the adherence to Good Clinical Practice (GCP) guidelines, regulatory standards, and ethical considerations throughout the clinical trial process. Ensure that all trials comply with local and international regulatory agencies, including the FDA and EMA.

Project Management: Manage the day-to-day operations of clinical trials, including timelines, budgets, and resources. Monitor the progress of trials, identify risks, and implement corrective actions as necessary to keep projects on track and within scope.

Cross-Functional Collaboration: Work closely with internal teams, including research and development, medical affairs, and regulatory affairs, to ensure seamless communication and alignment. Foster strong relationships with external vendors, CROs, and investigators to optimize trial operations.

Data Management & Analysis: Ensure accurate and timely data collection, monitoring, and analysis throughout clinical trials. Collaborate with data management teams to ensure data integrity, assist in resolving issues, and facilitate data review for regulatory submissions.

Patient Safety & Risk Management: Oversee patient safety during clinical trials by ensuring that monitoring, adverse event reporting, and safety protocols are in place. Address any concerns related to patient safety and ensure mitigation strategies are implemented in a timely manner.

Budget & Resource Management: Develop and manage budgets for clinical trials, ensuring efficient use of resources. Track expenditures and provide regular updates on financial performance, identifying opportunities to reduce costs while maintaining trial quality.

Stakeholder Communication: Serve as the primary point of contact for internal and external stakeholders, including senior management, regulatory bodies, and clinical partners. Provide updates on trial progress, challenges, and outcomes, ensuring transparency and alignment with strategic goals.

Trial Documentation & Reporting: Ensure all trial-related documentation, including protocols, amendments, and reports, are accurate, complete, and filed in compliance with regulatory standards. Lead the preparation of clinical trial reports and submissions for regulatory approval.

Continuous Improvement: Drive continuous improvement in clinical trial processes by evaluating outcomes, identifying areas for efficiency, and implementing best practices. Stay informed about advancements in drug delivery systems and clinical trial methodologies to contribute to innovation in the field.

What the Client is Looking for in You

As the Clinical Trials Manager – Drug Delivery Systems, the client is looking for a dedicated and experienced professional who excels in managing complex clinical trials and has a strong background in drug delivery systems. You should be a strategic, detail-oriented leader who can oversee clinical trials from planning to execution while ensuring the highest standards of quality, compliance, and efficiency.

Proven Experience in Clinical Trials Management

The client seeks a Clinical Trials Manager with significant experience managing clinical trials, particularly in the pharmaceutical or biotechnology sectors. You should have a proven track record in overseeing all phases of clinical trials, from Phase I through Phase III, ensuring adherence to timelines, budgets, and regulatory requirements. Experience in drug delivery systems is highly desirable, as this role involves working with cutting-edge technologies that require a thorough understanding of clinical trial design and management.

Strong Knowledge of Regulatory Requirements

A deep understanding of regulatory standards, including GCP, FDA, and ICH guidelines, is essential. The client is looking for someone who can navigate the complexities of clinical trial regulations and ensure that all trials are compliant with local, national, and international requirements. The ability to liaise with regulatory agencies and prepare submission documents will be critical to the role’s success.

Leadership and Team Management Skills

As the Clinical Trials Manager, you will be responsible for leading cross-functional teams, including clinical research associates, data managers, and other professionals. The ideal candidate will have experience managing and mentoring teams, driving collaboration, and ensuring all members work towards common goals. You should be able to provide guidance, maintain high performance, and promote a culture of accountability and innovation.

Exceptional Project Management Abilities

The client is looking for a candidate with strong project management skills, including the ability to plan, execute, and monitor complex clinical trials. You should be adept at managing multiple tasks simultaneously, identifying potential risks, and proactively addressing any challenges. Your ability to manage resources efficiently and ensure trial milestones are met will be critical in driving the success of clinical trials.

Ability to Analyze and Interpret Data

The Clinical Trials Manager must possess excellent analytical skills, with the ability to interpret complex data from clinical trials. The client values someone who can work closely with data management teams to ensure accurate data collection and provide actionable insights for improving trial processes. Experience with clinical trial management systems (CTMS) and data analysis tools is a plus.

Commitment to Patient Safety and Ethical Practices

The client places a strong emphasis on patient safety and ethical standards in clinical trials. You should have a keen awareness of patient welfare, ensuring that all trials are conducted with the highest ethical standards in mind. The ability to respond quickly to safety concerns and implement mitigation strategies is essential to maintaining trust and regulatory compliance.

Communication and Stakeholder Management

As the Clinical Trials Manager, you will interact with a variety of stakeholders, including internal teams, external vendors, clinical investigators, and regulatory bodies. Strong communication skills, both written and verbal, are essential for presenting trial progress, risks, and outcomes to stakeholders, ensuring transparency, and maintaining strong relationships.

Drive for Continuous Improvement

The client values professionals who are committed to continuous improvement. You should have a passion for optimizing clinical trial processes, incorporating new technologies, and driving innovation in the field of drug delivery systems. Staying up-to-date with the latest industry trends and best practices will be crucial to delivering high-quality trial outcomes.

FAQs About the Role – Clinical Trials Manager – Drug Delivery Systems

What are the key responsibilities of the Clinical Trials Manager in this role?

As the Clinical Trials Manager, you will be responsible for overseeing the planning, execution, and monitoring of clinical trials related to drug delivery systems. Your role will involve managing trial timelines, budgets, resources, and cross-functional teams, ensuring regulatory compliance, patient safety, and data integrity. You will also be responsible for communicating progress to stakeholders, managing trial-related documentation, and ensuring that trials meet the highest industry standards.

What qualifications and experience are required for this position?

The ideal candidate should have significant experience in clinical trial management, with a focus on drug delivery systems. A strong background in clinical research, including experience in Phase I-III clinical trials, is essential. You should be familiar with regulatory requirements (e.g., GCP, FDA, ICH guidelines) and have a proven ability to manage multiple trials simultaneously. A degree in Life Sciences or a related field is required, and certifications in Clinical Research (e.g., CCRP) are a plus. A background in pharmaceutical or biotech industries is highly preferred.

What leadership qualities are essential for this role?

The client is looking for a proactive leader who can manage and motivate cross-functional teams, ensuring that everyone works towards the successful completion of clinical trials. You should have strong communication skills, the ability to problem-solve in high-pressure situations, and a commitment to maintaining high standards of patient safety and trial quality. Experience in managing diverse teams and working with external stakeholders is also critical.

What challenges can I expect in this role?

Managing clinical trials involves several challenges, such as ensuring compliance with complex regulations, mitigating risks, managing tight timelines, and navigating the complexities of drug delivery systems. You will need to be adaptable in responding to unexpected issues, such as recruitment delays or adverse events, and constantly evaluate and optimize trial processes to improve efficiency and outcomes. Balancing operational excellence with innovation in drug delivery systems is also a key challenge.

What is the expected impact of the Clinical Trials Manager on the company’s success?

The Clinical Trials Manager will have a direct impact on the company’s ability to successfully advance drug delivery systems through clinical trials, ultimately influencing the development and market approval of groundbreaking therapies. Your work will be critical in ensuring that clinical trials are executed on time, within budget, and in compliance with all regulatory requirements, directly contributing to the company’s ability to bring innovative treatments to market.

What is the company’s culture and work environment like?

The company fosters a collaborative and research-driven environment that values innovation and operational excellence. They encourage employees to take ownership of projects, collaborate across departments, and continuously improve processes. As a Clinical Trials Manager, you will work with a team of passionate professionals who are dedicated to advancing healthcare through cutting-edge drug delivery technologies. The work environment is fast-paced, with a strong focus on integrity, patient safety, and regulatory compliance.

What Remuneration Can You Expect from This Job?

As the Clinical Trials Manager – Drug Delivery Systems in Raleigh-Durham, NC, you can expect a highly competitive compensation package tailored to your experience, qualifications, and the level of responsibility this role demands. The remuneration for this position typically includes:

Base Salary

The base salary for a Clinical Trials Manager in the drug delivery systems sector will vary based on factors such as company size, experience, and regional market conditions. Typically, the annual base salary ranges from $90,000 to $150,000, with higher salaries being offered by larger companies or those with more complex trials.

Performance-Based Bonuses

In addition to the base salary, you may be eligible for performance-based bonuses. These bonuses are typically tied to the successful execution of clinical trials, meeting timelines, managing trial budgets, and achieving key milestones in the development of drug delivery systems. Bonuses can range from 10% to 25% of the base salary, depending on individual and company performance.

Equity & Stock Options

Many organizations offer equity-based incentives as part of their overall compensation packages. As a Clinical Trials Manager, you may be offered stock options or restricted stock units (RSUs) that tie your financial rewards to the long-term success and growth of the company. These equity incentives can provide significant financial upside, particularly if the company experiences rapid growth or successful product development.

Profit-Sharing & Long-Term Incentive Plans (LTIPs)

Some companies may provide profit-sharing arrangements or LTIPs to reward high-level managers for contributing to the company’s long-term success. These plans incentivize sustained performance and may offer additional financial rewards based on achieving key company or trial milestones.

Executive Benefits & Perks

As a Clinical Trials Manager, you can expect a comprehensive benefits package, which may include:

Health, dental, and vision insurance
401(k) or pension plans with company contributions
Life and disability insurance
Paid time off (PTO) and sick leave
Wellness programs and gym memberships
Travel allowances for site visits or conferences

Signing Bonuses & Relocation Assistance

For top candidates, especially those relocating for the role, companies may offer signing bonuses or relocation assistance to help offset the costs associated with moving. These one-time incentives can range from $5,000 to $25,000, depending on the company and the candidate’s experience and location.

Total Compensation Potential

When considering the base salary, performance bonuses, stock options, and benefits, the total annual compensation for a Clinical Trials Manager in the drug delivery systems industry can range from $100,000 to $200,000, or more, depending on the scope of the role, the company’s growth potential, and your individual contributions to trial successes and operational efficiency.

How to Apply

If you are an experienced and results-driven Clinical Trials Manager with a strong background in drug delivery systems, we invite you to apply for this exciting opportunity in Raleigh-Durham, NC. This is your chance to lead impactful clinical trials, manage cross-functional teams, and contribute to the development of cutting-edge drug delivery technologies.

To apply, please submit your resume along with a cover letter that highlights your experience in clinical trial management, drug delivery systems, regulatory compliance, and team leadership. Be sure to emphasize your ability to manage complex trials, deliver on time and within budget, and ensure the highest standards of patient safety and data integrity.

In your cover letter, please include details of your previous experience in managing clinical trials from planning through execution, your familiarity with regulatory guidelines (GCP, FDA, ICH), and your ability to lead teams and communicate effectively with stakeholders.

This role offers a unique opportunity to make a lasting impact on the development of innovative therapies. If you’re ready to take the next step in your career as a Clinical Trials Manager in Drug Delivery Systems, apply today!

For more information about this position or to explore similar opportunities in clinical trials management, please visit our Clinical Trials Careers Page.

Job Category: Drug Delivery Systems

Job Type: Full Time

Job Location: Raleigh-Durham

Clinical Trials Manager – Drug Delivery Systems – Raleigh-Durham, NC