Job Title: Manager, Study Management
Location: Remote
Duration: 12 Months (Possibility of Extension)
 
Overview:
Seeking an experienced Study Management contractor to support global, industry-sponsored clinical trials under the guidance of a Senior Manager. The role focuses on hands-on study execution, vendor oversight, and operational delivery while ensuring activities align with timelines, quality standards, and regulatory requirements.
 
Key Responsibilities:

1. Support end-to-end study execution from start-up through close-out under Senior Manager guidance.
2. Provide day-to-day oversight of external vendors including Clinical Research Organizations (CROs), central labs, and imaging providers.
3. Monitor vendor performance and escalate risks, issues, and mitigation plans when needed.
4. Ensure compliance with Good Clinical Practices (GCP), FDA regulations, and global regulatory guidelines.
5. Lead study-level operational activities and support cross-functional collaboration.
6. Identify and resolve operational challenges with key stakeholders.

 
Required Experience & Skills:

1. Experience working on industry-sponsored global clinical trials.
2. Hands-on experience managing external vendors (CROs, labs, imaging providers).
3. Strong understanding of GCP, FDA regulations, and international guidelines.
4. Ability to identify issues early and implement solutions in clinical development environments.
5. Strong written and verbal communication skills.
6. Excellent organizational and project management abilities.
7. Proven ability to collaborate and lead across teams.

 
Soft Skills:

1. Strong written and oral communication
2. Flexibility and adaptability
3. Self-directed and proactive work style
4. Analytical problem-solving
5. Effective decision-making
6. Strong project management capability

 
Ideal Profile:
A hands-on, execution-focused study manager who works well in matrixed environments, collaborates across teams, and ensures CRO and vendor accountability to support high-quality global trial delivery.
 
Basic Qualifications:

• Doctorate degree, OR
• Master’s degree + 2 years experience, OR
• Bachelor’s degree + 4 years experience, OR
• Associate’s degree + 8 years experience, OR
• High school diploma/GED + 10 years experience

 
Top 3 Must-Have Skill Sets:

1. Hands-on study management and clinical trial execution
2. Cross-functional collaboration in matrixed environments
3. CRO/vendor oversight and accountability

 
Top 3 Non-Negotiables:

1. Strong written and oral communication skills
2. Initiative and self-directed work style
3. Strong project management skills

 
Day-to-Day Responsibilities:

1. Manage study execution from start-up through close-out.
2. Oversee CROs, central labs, imaging vendors, and service providers.
3. Track vendor performance, risks, and mitigation strategies.
4. Maintain GCP and regulatory compliance.
5. Coordinate study operations and cross-functional activities.
6. Resolve operational issues with internal teams and stakeholders.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 56.25/daily.