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About the Role

The Senior Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies. This role is a recognized resource in protocol execution, product and disease state knowledge, procedure support, clinical trial enrollment, and GCP compliance. The individual will lead training, manage site performance, and ensure compliance with regulatory requirements.

Responsibilities

Develop and maintain a productive clinical territory by identifying and developing sites capable of meeting study goals.
Understand and assess investigator interests and qualifications.
Identify appropriate investigators based on study-specific requirements and regulatory codes.
Maintain open communication and relationships with key site personnel.
Provide ongoing technical support to customers and field staff.
Facilitate communication between clinical sites and other Abbott clinical staff.
Manage all aspects of the study lifecycle, including site regulatory and quality.
Oversee site nomination, qualification, and startup processes.
Facilitate all aspects of the start-up process and site initiation visits.
Understand regulatory and legal requirements for study participation.
Train facility staff regarding protocol requirements and technology.
Develop site-specific strategies to promote appropriate patient enrollment.
Identify site successes and challenges and assist in implementing techniques to achieve study goals.
Continuously evaluate site study performance and provide timely feedback.
Attend study procedures and follow-ups when indicated.
Develop site-specific strategies to avoid deviations.
Educate sites on tools to facilitate compliance.
Provide timely feedback to sites on key compliance indicators.
Escalate non-compliant sites according to corporate policy.
Collect essential documents, identify and obtain missing data, data corrections, review adverse events and protocol deviations.
Review data and source documentation from investigational sites for accuracy and completeness.
Facilitate resolution of data queries and action items at clinical sites.
Promptly report the findings of monitoring visits according to Abbott processes.
Maintain accurate, detailed, and complete records of monitoring visits.
Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.
Provide clinical and technical expertise for clinical trial procedure support as needed.
Collaborate in the education of local sales groups on new product launches when appropriate.
Contribute to the education of customers on new and existing Abbott products when appropriate.
Meet with key customers where Abbott GCO presence can elevate the customer experience.
Act as an additional resource for technical questions and troubleshooting.
Identify and adapt to shifting priorities and competing demands.
Remain current on developments in the field of expertise, including clinical and Abbott product knowledge, competitive positioning, and published scientific and economic evidence.
Maintain at least one area of expertise and function as a local clinical and technical resource.
Possess independent problem-solving skills and ability to make decisions.
Exhibit excellent oral and written communication skills.

Requirements

Bachelor's degree in engineering, science, health science, nursing, or a related field.
2 years of progressively more responsible relevant clinical trial experience in the cardiovascular field.
Ability to travel approximately 50%.

Skills

Protocol execution
Product knowledge
Disease state knowledge
Procedure support
Clinical trial enrollment
ICH-GCP and clinical research application
Site nomination
Site qualification
Site startup processes
Training and retraining of site stakeholders
Recruitment performance management
Data collection performance management
Operational metrics utilization
Regulatory requirements compliance
Good Clinical Practice compliance
Accuracy standards
Site initiation visits
Periodic visits
Close-out visits
Study design consultation
Site payments consultation
Site audits consultation
Local document review
Study documents preparation
Submission to site or competent authority/ethics committee
Investigator assessment
Customer relationship management
Field staff support
Clinical site communication
Study lifecycle management
Regulatory and quality management
Catheterization lab protocol and procedures
Operating room protocol and procedures
Patient enrollment strategies
Site performance evaluation
Study procedure attendance
Deviation avoidance strategies
Compliance facilitation
Essential document collection
Data query resolution
Action item resolution
Monitoring visit reporting
Monitoring visit record maintenance
Clinical expertise application
Technical expertise application
Commercial launch training
Commercial partner collaboration
Customer education
Technical question support
Troubleshooting
Problem-solving
Decision making
Oral communication
Written communication

Location

Cleveland, OH
Buffalo, NY

Work Type

Field-based
Full-time

Experience Level

Senior
2 years of progressively more responsible relevant clinical trial experience

Education Level

Bachelor's degree

Salary/Compensations

$78,000.00 – $156,000.00

Benefits

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution.
Tuition reimbursement.
Freedom 2 Save student debt program.
FreeU education benefit.
Health and wellness benefits.

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life.
Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Our 122,000 colleagues serve people in more than 160 countries.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Equal Opportunity

Abbott is an Equal Opportunity Employer, committed to employee diversity.