Senior Clinical Site Lead

Job Description

Senior Clinical Site Lead

Summary

The Senior Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Advanced subject matter resource in protocol execution, multiple product and disease state knowledge, procedure support (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application 

Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training/retraining of all site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences all aspects of site’s recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Proactively utilizesappropriate operational metrics to minimize screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits. 

May be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee. Beyond developing and maintaining a productive clinical territory, the Senior Clinical Site Lead is a recognized leader and expert that provides support, mentoring and guidance to other clinical site management colleagues and supports key projects/initiatives in Global Clinical Operations and/or Business Units.  

Main Responsibilities

With limited direction from leadership: 

Develop and maintain a productive clinical territory: 

• Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality. 

• Understand and assess investigators’ interests and qualifications.  

• Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code. 

• Maintain open communication and relationships with key site personnel including the Principle Investigator, Research Coordinator, as well as regulatory and legal personnel. 

• Provide ongoing technical support to customers and field staff. 

• Facilitate communication between clinical sites and other Abbott clinical staff (e.g., operations management, study team, Site Contracts Associate), as needed. 

Manage all aspects of study lifecycle to include site regulatory and quality: 

• Start Up 

• Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution. 

• Facilitate all aspects of the start-up process and site initiation visits 

• Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Abbott clinical staff, e.g. Site CRA, Site Contract Associate.  

• Train facility staff regarding protocol requirements and technology. 

• Enrollment 

• Develop site-specific strategies to promote appropriate patient enrollment. 

• Identify site successes and challenges and assist in implementing techniques that promote study goal achievement. 

• Continuously evaluate site study performance and provide timely feedback to site. 

• Attend study procedures and follow-ups when indicated (or ensure trained personnel attend). 

• Regulatory and Quality  

• Advanced level Abbott certification and/or equivalent level proficiency

• Develop site-specific strategies to avoid deviations. 

• Educate site on tools to facilitate compliance. 

• Provide timely feedback to the sites on key compliance indicators. 

• Escalate non-compliant sites according to corporate policy. 

• Collect essential documents, identify and obtain missing data, data corrections, reviewing 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 reports the findings of monitoring visits according to Abbott processes. 

• Maintain accurate, detailed and complete records of monitoring visits. 

Provide training and procedure coverage:   

• Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches. 

• As needed, provide clinical and technical expertise for clinical trial procedure support 

• Attend study procedures and follow-ups (or ensure trained personnel attend). 

Territory Optimization, Expanded Clinical/Technical Expertise, and Contributions beyond Territory 

• Proactively, and with minimal oversight, look for ways to facilitatestrong performance and capabilities of study sites within their territory. 

• Use critical thinking to identify issues, address them, and create plans to augment success or prevent recurrence of variances from site expectations.  

• Work with sites to develop capabilities to take on more complex and diverse trials, or larger volume of trials.  

• Communicate to leadership and study teams proactively and in a timely manner, all study and site updates critical to clinical priorities.  

• Identify and share best practices for territory management. 

• Deepen area(s) of expertise and function as a regional clinical and technical resource. 

• Utilize effective communication skills in difficult conversations with key stakeholders. 

• Contribute additional value to the organization beyond primary responsibilities which may include but are not limited to: 

• Provide feedback on protocol development, execution, and study tools. 

• Provide feedback on product performance.  

• Actively participate in a Therapy Council.  

• Act as a mentor to other Site Management staff.  

Collaborate with commercial partners: 

• When appropriate, 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. 

• 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. 

• Develop working knowledge of disease states and product lines for all relevant Abbott clinical trials. 

• Upon leadership approval, complete and maintain certifications that are relevant to specific field(s) of expertise (where appropriate).

Possess independent problem-solving skills and ability to make decisions. 

Exhibit excellent oral and written communication skills. 

Required Qualifications:

• Associates Degree (+13 years) 

• Minimum 7 years of related experience 

Preferred Qualifications:

• Bachelor’s Degree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research.  

• 3 years of progressively more responsible relevant clinical trial experience in the cardiovascular field.  

• Competency in catheterizaion lab and operating room protocol and procedures.  

• Ability to appear onsite to support team collaboration operational need

• Ability to travel approximately 30% domestically