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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading programming deliverables within clinical study teams, with strong organizational and documentation skills in regulated environments. Capable of managing project deliverables and collaborating effectively with multidisciplinary teams to ensure timely regulatory approval and product launch.
Highest-signal resume keywords
Clinical Study Team LeadershipProject ManagementRegulatory Approval ProcessPerformance EvaluationSAS Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Programming DeliverablesData ManagementDocumentation SkillsQuality ControlAd Hoc Requests Handling
Soft Skills
Organizational SkillsCollaborationFeedback Provision
Certifications & Qualifications
SAS Certification
Industry Keywords
Therapeutic Area ExpertiseRegulated EnvironmentResource ManagementPerformance EvaluationsInformation Retention Procedures
About the role
Key responsibilities & impact- Develop expertise within a therapeutic area or standard tool
- Coordinate and oversee project deliverables
- Lead development and quality control of tables, listings, and graphs
- Manage programming effort and track deliverable progress and completion
- Handle complex ad hoc requests
- Serve as programming representative on multidisciplinary study teams
- Provide timely support through regulatory approval and product launch
- Partner with management to determine resource requirements
- Review resumes and screen candidates for contractor and permanent roles
- Provide feedback on team members' contributions for performance evaluations and goal-setting
- Advise direct reports on data, records, and information retention procedures
- Collaborate with study teams, CROs, and cross-functional colleagues
Requirements
What you’ll need- Master's degree with 6+ years of relevant work experience, or BS with 7+ years of relevant work experience
- Proven experience leading programming deliverables within a clinical study team
- Experience providing input on hiring, feedback, and performance evaluation
- Strong organizational and documentation skills within a regulated environment
- SAS Certification nice to have
- Ability to work onsite in Warren, NJ or Cambridge, MA
- Ability to lead programming deliverables through regulatory approval, product launch, and annual reports
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required
