Job Title: Senior Study Manager

Job Description

The Senior Study Manager will be responsible for ensuring the delivery and execution of clinical studies across multiple geographic regions. This role requires adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations/EU Directives, and ICH guidelines. The incumbent will interact routinely with key internal and external stakeholders to communicate project status, escalate issues, and troubleshoot inquiries. The role involves managing clinical study plans, overseeing CROs and vendors, and ensuring study milestones are achieved within timelines and budget.

Responsibilities

• Ensure the delivery and execution of clinical studies across multiple geographic regions.
• Adhere to Good Clinical Practices (GCPs), SOPs, FDA regulations/EU Directives, and ICH guidelines.
• Communicate project status, escalate issues, and troubleshoot inquiries with key internal and external stakeholders.
• Lead the development of the clinical study plan, including critical path activities and interdependencies.
• Create and manage the cross-functional Clinical Study Oversight Plan (CSOP) and ensure adherence by the study team.
• Provide operational input into study protocol profiles, final protocols, and amendments.
• Lead the document review and coordination for protocols and amendments, including ICF, CRF guidelines, IB, and safety communications.
• Oversee the CRO and vendor selection process and manage the creation of the CRO scope of work.
• Lead trial feasibility and site identification activities in collaboration with the CRO and study team.
• Monitor clinical trial performance and quality metrics, and ensure actions are taken to address any issues or risks.
• Ensure adherence to internal procedures for study planning, conduct, closeout, and reporting.
• Assess potential risks to the study and propose mitigation plans.
• Monitor study budget against trial progress and bring deviations to the attention of the Operations Program Lead and study team leader.
• Review and approve vendor invoices, including investigator grants and pass-through costs.
• Ensure study budget reconciliation with Finance.
• Oversee and manage CROs and third-party vendors to ensure compliance with quality measures and adherence to scope of work within timelines and budget.
• Track operational study timelines and monitor performance metrics throughout the life of the study.
• Coordinate with CROs to prepare and execute meetings, including vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings, and training sessions.
• Oversee CRO study start-up activities and coordinate with functional groups to ensure essential site documents are collected and sites are initiated per study plan.
• Monitor site initiation and enrollment activities and develop mitigation strategies in collaboration with the CRO.
• Review CRO-generated reports and address areas of concern.
• Coordinate and liaise with internal functions for site audit and inspection activities.
• Conduct and/or oversee CRO oversight monitoring visits (CROOM visits).
• Coordinate all operational activities under the guidance of the study team leader.
• Liaise with CRO to support interim analysis, database lock, and review of TLG before and after database lock.
• Oversee CRO study close-out activities and liaise with internal functions to ensure drug destruction process and other study closeout activities are completed.
• Support department in codifying existing knowledge and best practices and prepare training in areas of expertise.
• Make recommendations for areas of improvement and innovation at the study or departmental level.
• Educate the team on adherence to SOPs, GCPs, and best application of operational tools.

Essential Skills

• Robust experience in clinical trial study start-up and enrollment boosting activities.
• Experience working with and overseeing CROs.
• Experience working on more than one oncology study.
• Experience with global studies, including regions such as Asia-Pacific and Latin America.
• Experience or awareness of protocol amendments.
• Vendor/CRO oversight and management experience.
• Recent oncology solid tumor experience with indications such as colon, rectal, cervical, GYN, GI, pancreatic, and breast cancer.
• 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.

Additional Skills & Qualifications

• Experience with EU CTR (nice to have).
• Prior experience working for a Japanese company (a plus).
• Prior experience working as a CRA (a plus).
• Ability to adapt quickly to a fast-paced environment.
• Ability to work collaboratively.
• Excellent written and oral communication skills.

Work Environment

Candidates must be in the Eastern Timezone or local to the NJ/PA/NY area. This is a 100% remote role, but candidates should be open to and flexible with face-to-face meetings.

Pay and Benefits

The pay range for this position is $85.00 - $95.00/hr.

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 is anticipated to close on Apr 8, 2025.

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 for other accommodation options.

Salary : $85 - $95