Senior Study Manager
Apply NowCompany: Actalent
Location: Philadelphia, PA 19120
Description:
Job Title: Senior Study Manager
Job Description
We are seeking a highly skilled and experienced Senior Study Manager to oversee the delivery and execution of clinical studies on a global level. This role involves managing a dynamic and ever-changing Pan Tumor Phase II study with multiple stages and patient enrollment requirements. The incumbent will ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and ICH guidelines.
Responsibilities
This is a 100% remote role, but candidates must be in the Eastern Time Zone or local to the NJ/PA/NY area and open to face-to-face meetings. The work environment is dynamic and requires flexibility and adaptability to changing project needs.
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 30, 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:
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.
Job Description
We are seeking a highly skilled and experienced Senior Study Manager to oversee the delivery and execution of clinical studies on a global level. This role involves managing a dynamic and ever-changing Pan Tumor Phase II study with multiple stages and patient enrollment requirements. The incumbent will ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and ICH guidelines.
Responsibilities
- Ensure the delivery execution of clinical studies across multiple geographic regions.
- Maintain routine interaction with key internal and external stakeholders to communicate project status, escalate issues, and troubleshoot routine inquiries.
- Lead the development of the clinical study plan including critical path activities and interdependencies for assigned clinical studies.
- Develop and manage the Clinical Study Oversight Plan (CSOP) and ensure adherence by the study team and vendors.
- Provide operational input into study protocol profiles, final protocols, and amendments.
- Lead the CRO and vendor selection process and manage their performance and compliance.
- Monitor clinical trial performance and quality metrics and take necessary actions to resolve issues or escalate risks.
- Oversee site qualification, initiation, and enrollment activities, and develop mitigation strategies in collaboration with the CRO.
- Coordinate and execute meetings including vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings, and training.
- Review and approve vendor invoices and ensure the study budget is reconciled with Finance.
- Support department in codifying existing knowledge and best practices, and prepare training in areas of expertise.
- 7+ years of experience in clinical operations with a Pharmaceutical or Biotech company.
- Experience in clinical trial study start-up, enrollment boosting activities, and overseeing CROs.
- Experience with global studies, including regions such as Asia-Pacific and Latin America.
- Recent oncology solid tumor experience.
- Experience in leading phase II or III global studies.
- Bachelor's degree in Science or advanced degree.
- Excellent written and verbal communication skills.
- Strong decision-making abilities and attention to detail.
- Experience with EU CTR is a plus.
- Experience in protocol amendments.
- Prior experience working for a Japanese company is a plus.
- Prior experience working as a CRA is a plus.
- Ability to adapt quickly to a fast-paced environment.
- Ability to work collaboratively.
This is a 100% remote role, but candidates must be in the Eastern Time Zone or local to the NJ/PA/NY area and open to face-to-face meetings. The work environment is dynamic and requires flexibility and adaptability to changing project needs.
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 30, 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.