Abbott Senior Clinical Study Manager in Burlington, Massachusetts
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
We are seeking an experienced, high caliber Clinical Study Manager who will be responsible for managing and meeting the objectives of clinical projects. The Clinical Study Manager internally interfaces 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).
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.
Impact this role will have on Abbott:
Determines project objectives, strategy, scope and schedule to meet business needs.
Develops the project Plan in consultation with the cross-functional project team, project stakeholders and the clinical team.
Presents project plans, provides ongoing updates, and presents project results to SJM senior clinical management.
Assists in the management and execution of the clinical project.
Ensures all SJM staff are trained on the requirements of the clinical project and project plan.
Responsible for ensuring the clinical project is “audit ready” at all times (project team training records, central files, system validation, etc.).
If applicable, ensures adequate monitoring is conducted on all clinical project
Conducts clinical visits as needed to support clinical project.
Enlists support and specifies tasks for various team members to assure meeting objectives are completed on schedule.
Provides oversight of clinical projects to ensure safety concerns and/or adverse events or trends in Field Events Reporting are identified and appropriate responses are developed and executed.
Provides clinical input and support for planning post-project activities and product market launch.
If applicable, authors/co-authors project results in medical literature plans and/or presents at scientific investigation meetings.
Controls device distribution and allocation.
Monitors project reports for accuracy and trending.
Provides input to project budgets and project plans.
Provide clinical scientific support to project teams.
Evaluates clinical data in preparation of study summary reports for presentations, publications, and submissions.
Develops and implements corrective actions as needed to address any noncompliance issues.
Performs LA Reviews of marketing materials related to clinical project.
Communicates with and provides updates to specific core teams.
Oversees activities delegated by Sr. Clinical Research Manager or Sr. Director, Clinical.
Provides input and support for planning post-trial clinical activities and product market launch.
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Your required experience(s), education and knowledge will further expand Abbott’s marketplace success:
Bachelor’s degree (technical or non-technical). Technical degree defined as engineering, biological sciences or related medical/scientific field.
Minimum 3-5 years’ experience directly supporting clinical research or similar experience in a medical/scientific area.
1-3 years’ experience managing projects, strong project management skills are needed.
Experience working with clinical professionals within a team.
Experience 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.
High attention to detail and accuracy.
Advanced written and oral communications skills.
Able to manage multiple tasks.
Proficient knowledge of medical terminology.
Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA).
Strong problem-solving skills.
Advanced knowledge of clinical and outcomes research study design.
Strong computer skills.
Demonstrated ability to work effectively on cross-functional teams.
Clinical Affairs / Statistics
ASJM Abbott St. Jude Medical
United States > Massachusetts > S4502 : 168 Middlesex Turnpike
Yes, 25 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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