Clinical Trial Manager (Pediatric Trials)

Responsibilities:

• Excellent employment opportunity for a Clinical Trial Manager in the Ridgefield, CT area. Remote Position
• 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 investigation sites.
• Represents the company for the function at internal and external meetings, e.g. with investigation sites or regulatory agencies/inspectors.
• Failure can have impact on project deliverables (e.g. timelines, costs, integrity of trial data), the reputation of the company 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.

Experience:

• 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.
• Experience with inflammation clinical trials, especially with dermatologist is preferred
• 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).