allied executive solutions
allied executive solutions
Allied Executive Solutions is a consulting firm serving non-profit and social-impact organizations. Its work combines research and development, grant management, and executive support to help mission-driven teams strengthen their operations, pursue sustainable growth, and create lasting benefits for the communities they serve. The company focuses on tailored support designed around each organization’s goals and needs.

Clinical Trials Project Manager (Hybrid, United States)

Manage clinical trials from study start-up through close-out for an allied research institute. Oversee timelines, budgets, vendors, regulatory compliance, and cross-functional trial teams.

Description

  • Create and maintain project plans, schedules, budgets, and risk strategies for assigned clinical trials
  • Direct daily trial activities across start-up, enrollment, monitoring, and close-out
  • Coordinate communication among sponsors, CROs, investigators, IRBs/ECs, and internal stakeholders
  • Manage clinical trial site selection, activation, and performance
  • Monitor trial spending, forecast costs, and oversee vendor and CRO contracts and deliverables
  • Maintain compliance with ICH-GCP, FDA and EMA regulations, and applicable local laws
  • Monitor and report enrollment, data quality, and progress against study milestones
  • Evaluate and mitigate risks and issues that could affect timelines, budgets, or quality
  • Partner with Data Management, Biostatistics, Regulatory Affairs, and Pharmacovigilance teams
  • Maintain trial records, including the Trial Master File, and support inspection readiness
  • Facilitate internal meetings, sponsor discussions, and investigator meetings
  • Assist with audits and regulatory inspections when required
  • Advance the organization’s mission, values, and commitment to ethical research
  • Collaborate with patients, research participants, clinical staff, investigators, sponsors, monitors, and community partners

Requirements

  • Bachelor’s degree in life sciences, nursing, public health, or a related discipline
  • At least 3–5 years of experience in clinical trial management, clinical research, or clinical operations
  • Working knowledge of ICH-GCP and relevant regulatory requirements, including FDA and EMA frameworks
  • Background managing project schedules, budgets, and vendor relationships
  • Familiarity with Phase I–IV clinical trials and varied study designs
  • Strong organization, problem-solving, and communication abilities
  • Experience using clinical trial management systems, EDC platforms, and Microsoft Project or Excel
  • PMP, CCRA, ACRP, or SoCRA certification is preferred
  • Experience overseeing multi-site or global clinical trials is preferred
  • Relevant therapeutic-area experience is preferred
  • Experience collaborating directly with CROs and central laboratories is preferred
  • Ability to safeguard research participants’ rights, safety, dignity, and confidentiality
  • Ability to follow organizational policies, study protocols, regulatory obligations, and compliance standards
  • Local travel, evening work, or flexible scheduling may be required based on study needs

Benefits

  • Equal opportunity employment
  • Access to training opportunities
  • Participation in team meetings and quality improvement activities
  • Performance review processes
  • Flexible scheduling may be available based on study needs

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