Clinical Trial Manager -- KAPDC6156749

Compunnel Inc.; United States; Remote; USD 120,000 - 150,000; Full time

Job summary

Compunnel Inc. is seeking a Clinical Trial Manager focused on pediatric trials. The role manages the local component of global studies, ensuring recruitment, timelines, and budgets are met while coordinating with investigators, CRAs, and vendors.

Ideal candidates will have 6+ years in clinical research (pediatrics preferred) and experience navigating GCP and regulatory requirements. Domestic travel 10–20% is required; the position is fully remote within the United States.

Qualifications

• Bachelor's degree with at least 6 years in clinical research, preferably in pharma.
• Master's/PharmD with at least 4 years in clinical research preferred.
• PhD/MD with at least 2 years in clinical research preferred.
• Experience in pediatric clinical trials is required.

Responsibilities

• Oversee local component of a global trial and ensure recruitment, timelines and budget adherence.
• Coordinate with site staff, CRAs, investigators and external stakeholders.
• Ensure trial conduct complies with regulatory requirements and safety standards.
• Balance multiple assignments and lead local trial team across planning, conduct and closeout.
• Travel domestically about 10–20% as needed.

Skills

Pediatric trials

Cross-functional leadership

Project management

Regulatory knowledge

Communication in matrix organizations

Education

Bachelor's degree + 6+ years clinical research experience

Master's degree or PharmD + 4+ years

PhD or MD + 2+ years

Job description

Job Title: Clinical Trial Manager – Pediatric Clinical Trials

Location: Fully Remote (Ridgefield, CT)

Duration: 12 Months (Possible extension or conversion)

Experience with Pediatric clinical trials is needed.

As clinical trial manager (CTM), accountable for the operational management of the local component of a clinical trial. Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.

Supports local trial team to ensure integrity of trial conduct, assurance of patient safety, and that local/regional component of trial is planned, conducted and reported in line with regulatory requirements. Requires orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial.

Works within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites. Represents the company for the function at internal and external meetings, e.g. with investigational sites or regulatory agencies/inspectors. Failure can have impact on project deliverables (e.g. timelines, costs, integrity of trial data), the reputation of BI with stakeholders and regulatory agencies. More than one assignment in parallel requires balancing conflicting priorities. Is involved in design and implementation of new innovative method as working group member.

Support the local trial team as an OPU Clinical Trial Manager (CTM)

Trial Preparation, Conduct and Closeout:

In collaboration with Site Monitoring Lead and CRAs, ensure

Trial contact for CRAs, investigators and site staff.

Skills:

Experience with Pediatric clinical trials

Strong communication skills in complex cross-functional matrix structures. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Highly developed receptive communication skills and cultural sensitivity.

Solid project management, networking/stakeholder management and team leadership capability. Understanding of the scientific and/or technical components of the clinical development process, and associated regulatory requirements.

Technical Expertise: Demonstrates knowledge across all aspects of clinical trial operations and execution. Knowledge in a relevant Therapeutic Area is an asset. Dimensions of trial complexity for this project management role include protocol, trial subjects, sites, countries, suppliers. Ability to work across several studies and in different Therapeutic Areas.

Leadership and Influence: Candidate's skills and capabilities in addressing complex situations, resolving conflicts, horizontal and vertical influencing.

Strategic Mindset: Embraces cross-functional initiatives, applying innovative learnings Identifies risks and plans mitigation.

Coordination and Oversight: Candidate's skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources.

Ability and willingness to travel domestically (10-20% of time).

Education:

Bachelor's degree plus a minimum of 6 years of experience in clinical research, preferably in the pharmaceutical industry; or

Master's degree or PharmD plus a minimum of 4 years of experience in clinical research, preferably in the pharmaceutical industry; or

PhD or MD plus a minimum of 2 years of experience in clinical research, preferably in the pharmaceutical industry.

Compunnel Inc. is an Equal Employment Opportunity (EEO) employer committed to fostering an inclusive, diverse, and equitable workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, citizenship status, age, disability, protected veteran status, marital status, genetic information, or any other characteristic protected by applicable federal, state, or local law.

As a global workforce solutions provider, Compunnel values diversity of thought, background, and experience, and believes an inclusive workforce strengths…