Clinical Development Consultant - United States
Want to know company name or location? Company managed [?]
- We unite caring with discovery to make life better for people around the world.
- Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
- We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
- Business Management: Site level accountability from Site Selection through Site Closeout.
- Primary point of contact for institutions to identify and proactively resolve business process barriers.
- Partnering with other functional partners and vendors interacting with the sites and serving as the single point of accountability for the site (site selection, site activation, enrollment, data delivery, issue management, and closeout).
- Influence the development and implementation of site initiation/enrollment risk plans for clinical trials to ensure delivery on enrollment commitments.
- Own the issues management process at the site level, collaborating with company partners, Quality, and other team members through both formal and informal interactions to resolve/escalate site specific issues when necessary.
- Oversee the delivery of data and clinical trial milestones at the site level. Leverage strategic knowledge of institution’s decision making process along with historical performance with other company clinical trials to deliver mutually acceptable business solutions.
- Business Development: Identify, screen, evaluate and develop investigators for clinical trial participation. Influence the design of clinical study protocols including input to study manager on protocol and enrollment feasibility for studies to enable the successful enrollment and implementation of the clinical trial.
- Maintain technical expertise within a therapeutic area to engage in scientific discussions with the investigator and institution personnel.
- Develop and maintain relationships with therapeutic clinical trial sites. If applicable, negotiate budgets and contracts with institutions and investigators with an emphasis on usage of standard agreements and Fair Market Value (FMV). Communication/Information Management:
- Serve as the primary sponsor point of contact for site personnel relative to clinical trial related issues.
- Serve as an effective communication “bridge” between our sites, third party vendors, and company Compliance:
- Oversee site level accountability for inspection readiness throughout the trial and in support of regulatory inspections.
- External Influence: Influence and challenge internal and external environmental factors that impact clinical research strategy.
- Bachelor’s Degree in a scientific field or health-related field with no less than 2 years experience in Pharmaceutical Clinical Trials/Development/Sales and good working knowledge of Good Clinical Practice. Qualified candidates must be legally authorized to be employed in the United States.
- Our company does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Demonstration of leadership behaviors; ability to work cross-culturally, accept challenges and seek opportunities to remove barriers, lead decisively in the midst of ambiguity. Therapeutic expertise and knowledge of the internal portfolio for the targeted therapeutic area.
- Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed
- Demonstrated proactive problem solving through assessment and innovative, pragmatic solutions Demonstration of strong communication skills (written and verbal); ability to break down complexity into clear and concise messaging.
- Experience in professional networking/customer service with positive mutually beneficial outcomes.