ABBOTT LABORATORIES Associate Clinical Project Manager Salary in the United States

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 103,000 colleagues serve people in more than 160 countries.

Responsible for managing and meeting the objectives of clinical Investigational Device Exemptions (IDE) trial.  Interfaces internally with data management, biostatistics, regulatory, clinical research associates, trial coordinators, field clinical specialists, functional management, cross-functional team members and business alliance leads (sales and marketing). This role also will be responsible for assisting with development and management of a novel post approval type study. Employees act on their strong desire to make a difference, partner with others and put ideas into action. Employees are engaged by a work culture that is team-oriented, fast paced and progressive.

Job Duties:

•  Determines study objectives, strategy, scope and schedule to meet business needs.
• Develops the Investigational Plan in consultation with the cross-functional project team, investigators, and the clinical team.
• Presents study plans, provides ongoing updates, and presents study results to Abbott senior clinical management.  Assists in the selection, interfaces with, and assures training of investigators and center staff.
• Ensures all Abbott staff is trained on the clinical study.
• Responsible for ensuring the trial is "audit ready" at all times (project team training records, central files, system validation, etc.).
• Ensures adequate monitoring is conducted on all clinical trials.
• Conducts monitoring visits as needed.
• Enlists support and specifies tasks for various clinical team members to assure meeting study objectives are completed on schedule.
• Participates in the preparation and attends DMC meetings for the study.
• Provides oversight of clinical trials to ensure safety concerns and/or adverse events are identified and appropriate responses are developed and executed.
• Provides input and support for planning post-clinical activities and product market launch.
• Authors/co-authors study results in medical literature plans and/or presents at scientific investigation meetings.
• Controls device distribution and allocation.
• Provides direction to CRAs or CTSs as required.
• Monitors project reports for accuracy and trending.
• Assists in query generation and resolution.
• Provides input to study budgets and project plans.
• Provides clinical scientific support to project teams.
• Evaluates clinical data in preparation of study summary reports for presentations, publications, and submissions.
• Develops and implements site corrective actions as needed to address any noncompliance issues. 
• Writes and/or provides input to the monitoring plan.
• Conducts regular study team meetings.
• Communicates with and provides updates to specific core teams.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications: 

• Bachelor's degree (technical or non-technical). Technical degree defined as engineering, biological sciences or related medical/scientific field.
• Minimum 5 years’ experience directly supporting clinical research or similar experience in a medical/scientific area.
• 1-3 years’ experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.
• Master’s degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience. • Polished communicator- written documentation and oral presentations/ discussions/ meetings.
• Excellent reputation for building relationships across various levels of an organization.
• Organized, on-time, and detailed project management skills. Energized attitude.
• Proficient knowledge of medical terminology. 
• Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA).
• Advanced knowledge of clinical and outcomes research study design.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.  
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.