Job Title: Senior Clinical Study Manager

Job Description

The Senior Clinical Study Manager will be responsible for ensuring the delivery and execution of clinical studies across one or more geographic regions. This role requires adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directive, and International Conference on Harmonization (ICH) guidelines. The individual will routinely interact with key internal and external stakeholders to communicate project status, escalate issues, and troubleshoot routine inquiries. The position demands expert-level written and verbal communication skills, strong decision-making abilities, clinical project management skills, and attention to detail.

Responsibilities

• Ensure primary accountability for operational study level time, cost, and quality deliverables.

• Lead the development of the clinical study plan, including critical path activities and interdependencies for assigned clinical studies.

• Lead the creation of the cross-functional Clinical Study Oversight Plan and ensure adherence by the study team.

• Provide operational input into study protocol profiles, final protocols, and amendments.

• Lead document review and coordination for protocols and amendments, including additional medical writing tasks.

• Lead the CRO and vendor selection process and create the CRO scope of work in collaboration with Outsourcing Procurement Management.

• Oversee trial feasibility and site identification activities, monitor clinical trial performance and quality metrics, and ensure actions are taken to address issues or risks.

• Ensure adherence to internal procedures for study planning, conduct, closeout, and reporting.

• Monitor study budget against trial progress, review and approve vendor invoices, and ensure ongoing reconciliation with Finance.

• Oversee CRO and 3rd party vendor management and performance to ensure compliance with quality measures and adherence to scope of work.

• Coordinate with CRO for study start-up activities, site initiation, and enrollment activities.

• Prepare and execute meetings including vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings, and training.

• Review CRO-generated reports and resolve or escalate areas of concern as needed.

• Conduct and/or oversee CRO oversight monitoring visits and support interim analysis and database lock activities.

• Coordinate study close-out activities, including TMF reconciliation and drug destruction processes.

• Support the department in codifying existing knowledge and best practices, preparing training in areas of expertise, and making recommendations for improvements and innovation.

Essential Skills

• 7+ years of experience with a Pharmaceutical or Biotech company.

• Bachelor's degree in Science (4-year degree) or advanced degree.

• Experience in clinical operations leading phase II or III global studies.

• Expert-level written and verbal communication skills.

• Strong decision-making abilities.

• Clinical project management skills.

• Attention to detail.

Additional Skills & Qualifications

• Prior experience working for a Japanese company is a plus.

• Experience as a Clinical Research Associate (CRA) is a plus.

Work Environment

This is a 100% remote role, with a preference for candidates located in the NJ area who are open to and flexible with face-to-face meetings.

Duration

6-month contract with potential to extend

Pay and Benefits

The pay range for this position is $85.00 - $95.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Dec 31, 2024.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.