Clinical Trial Manager (Remote)

Aequor; Ridgefield (CT); On-site; USD 110,000 - 170,000; Full time

Job summary

Aequor is seeking an experienced Clinical Trial Manager to oversee the local component of a clinical trial, ensuring recruitment, timelines, budget adherence and quality standards. You will coordinate with the local trial team, integrate with other functions, and operate in a global, regulated environment.

The role requires working with investigators, sites, and regulatory agencies, with 10–20% travel. Strong leadership and strategic thinking are essential for success.

Qualifications

• Experience with pediatric clinical trials.
• Strong communication in complex cross-functional matrix structures.
• Solid project management, networking/stakeholder management and team leadership capability.
• Understanding of the scientific and/or technical components of the clinical development process and regulatory requirements.
• Technical expertise across clinical trial operations.
• Knowledge in a relevant Therapeutic Area is an asset.
• Ability to work across several studies and Therapeutic Areas.

Responsibilities

• Accountable for operational management of the local component of a clinical trial.
• Ensure recruitment, timelines, budget and internal/external quality standards are met.
• Support the local trial team to ensure integrity of trial conduct and patient safety; regulatory compliance.
• Orchestrate local trial team and integration with other functions as necessary.
• Work within a GCP/regulatory environment on global trials with international teams and stakeholders.
• Represent the company at internal and external meetings with investigational sites or regulators.
• Balance conflicting priorities when managing more than one assignment in parallel.
• Participate in design and implementation of new innovative methods as a working group member.
• Support the local trial team as an OPU Clinical Trial Manager (CTM).
• Trial preparation, conduct and closeout: collaborate with Site Monitoring Lead and CRAs; be trial contact for CRAs, investigators and site staff.

Skills

Pediatric trials

Cross-functional communication

Project management

Clinical development knowledge

Leadership & influence

Strategic mindset

Coordination & oversight

Travel readiness

Education

Bachelor's degree + 6 years clinical research

Master's or PharmD + 4 years

PhD or MD + 2 years

Job description

• 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.