Sr. Clinical Research Project Manager

The Sr Clinical Research Project Manager is responsible for overseeing and coordinating all activities for clinical trials at St. Jude. This position works closely with sites and/or the St. Jude study team and appropriate staff in each department at St. Jude to assist with all department operations tasks and requirements. The Project Manager will have responsibility for establishing and meeting timelines for department operations and ensuring the project progresses through all functional working groups within the department from the start of the project through completion. Candidates with experience and demonstrated success in process improvement and change management are preferred.

 

 

Job Responsibilities:

• Lead large complex institutional as well as St. Jude sponsored, multi-center trials, including regulatory, financial, and administrative aspects of the study.
• Provide clinical operations expertise to inform clinical trial operational feasibility and delivery, and development of study recruitment and retention strategies.
• Collaborate with pharmaceutical services, study teams, and external stakeholders to forecast study drug needs and develop study-specific supply chain operational plans.
• Lead contract drafting, negotiation, administration and renewal; resource/supply management; budget development and management for clinical trials/studies; and financial tracking and follow-up (e.g., reimbursements) for assigned projects.
• Proactively drive engagement between cross-functional teams (e.g., regulatory, finance, biosafety, IS), cross-institutional teams, and external groups (e.g., FDA, NIH) for effective execution of trials/studies.
• Drive stakeholder meetings for assigned trials/studies (e.g., PI meetings, CRO trainings, vendor meetings, collaborative study site meetings).
• Monitor project progress and site performance, communicate regular updates to leadership teams/key stakeholders, and address risks and delays.
• Lead development of standard operating procedures, and implementation of process improvements where feasible.
• Mentor and guide team members and ensure they have all the resources required, to complete their assigned tasks.
• Engage in hiring, performance management, and other people processes.
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Maintains regular and predictable attendance.

 

Minimum Education and/or Training:

• Bachelor’s degree in relevant area required.
• Master’s degree preferred.

 

Minimum Experience:

• Minimum Requirement: 6+ years of progressive experience in a related area (e.g., study design, clinical project management, research study management).
• Experience managing/leading at least 1-2 people preferred.
• Substantial clinical, academia, behavioral, pharmaceutical, biomedical, scientific, or related experience required.
• Substantial experience in managing clinical trials/studies in academic center, hospital, biomedical, or pharmaceutical industry.
• Clinical research background strongly preferred.
• Experience working with systems/processes related to clinical research studies and their maintenance/implementation, as applicable to own area.
• Significant experience working with relevant regulations and guidelines and supporting institutional compliance.
• Extensive experience leading projects/processes end to end including resource planning and management, budget planning and communication and collaboration with internal (cross-functional) and external (regulatory authorities) teams preferred.
• Proven performance in earlier role.
• Process improvement and change management experience highly preferred.

 

Special Skills, Knowledge and Abilities:

• Develops effective plans (including resources and assets) for large/ complex multi-center clinical programs/trials/studies based on understanding of different organizational processes and cross-functional teams.
• Drives delivery for complex clinical programs/trials/studies with clear oversight of plans, contracting, resourcing, and milestones.
• Communicates with critical internal/external stakeholders to drive consensus and accountability for project success, and mitigate program/study risks.
• Drives development of clinical project/trial management capabilities within organization.
• Assesses and ensures ICH GCP compliance throughout the conduct of clinical research studies within own area/site.
• Provides input and guidance in the study selection process, including site assessment for feasibility.
• Develops and implements both generalized and study-specific quality/risk management plans across sites and studies.
• Able to deliver results through others by setting stretch goals and holding them accountable.
• Coaches team members with concrete feedback and improvement ideas, including addressing employee relations concerns.
• Explores opportunities for development of direct reports that makes their work enriching, empowers them, and stretches their growth in lateral areas.

 

Compensation

In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $94,640 – $169,520 per year for the role of Sr. Clinical Research Project Manager.

 

Explore our exceptional benefits!

 

Diversity, Equity and Inclusion

St. Jude Children’s Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world—regardless of race, religion or a family’s ability to pay. Learn more about our history and commitment.

 

Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital’s roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.

 

St. Jude is an Equal Opportunity Employer

 

No Search Firms

St. Jude Children’s Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.