Clinical Trial Manager

• As a clinical trial manager (CTM), accountable for the operational management of the local component of a clinical trial.
• Level of oversight ensures achievement of trial recruitment commitments, timelines, budget, and internal/external quality standards.
• Supports the local trial team to ensure integrity of trial conduct, assurance of patient safety, and that the local/regional component of the trial is planned, conducted, and reported in line with regulatory requirements.
• Requires orchestration of the local trial team and integration with other functions as necessary throughout planning, conduct, and closeout of the 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 an 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 the design and implementation of a new innovative method as a working group member.
• Support the local trial team as an OPU Clinical Trial Manager (CTM)

1. Trial Preparation, Conduct and Closeout:
2. In collaboration with the Site Monitoring Lead and CRAs, ensure
3. Trial contact for CRAs, investigators, and site staff.

• 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, and 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, and 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).

• 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.

Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.