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Scientific & Clincal Affairs Manager, Biologics

Aesculap Biologics
Breinigsville, PA 18031
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    148287977
Aesculap Biologics


Scientific & Clincal Affairs Manager, Biologics

US-PA-Breinigsville

Job ID: 2021-19162
Type: Regular Full-Time
# of Openings: 1
Category: Clinical
Aesculap Biologics LLC

Overview

Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients lives.



Responsibilities

Position Summary:

The Manager of Scientific & Clinical Affairs will oversee, manage and is the primary point of contact for the day-to-day clinical operations aspects of MSA clinical studies/projects including, planning, initiating, monitoring, and communicating project goals and timelines accordingly.

Responsible for driving successful medical/scientific evidence generation, including overall studies management, data management, as well as projects requested by the organizations strategic business areas. This position ensures all study/project deliverables are met according to timeline budget, and resource requirements, and identifies and addresses challenges in a collaborative team environment.

Principal Duties Responsibilities:

  • Works with Associate Director of Medical Scientific Affairs (MSA) in all phases of clinical studies through concept, planning, conduct, and close-out; including study document development, site feasibility, qualification and start-up, IRB approval, monitoring, safety reporting, issue resolution, and vendor/CRO management.
  • Regularly track and communicate study/project status to relevant team members, functional areas and executive management, including site and subject level metrics, challenges and opportunities; prepare monthly/quarterly progress reports.
  • Works closely with the Director, MSA in the management of clinical monitoring, safety and data management and the biostatistics aspects of clinical studies
  • Manages and sets annual goals, objectives and development plans for clinical research associates, provide performance evaluations and feedback.
  • Facilitates study meetings, and study training as necessary, as well as attending surgeon trainings and clinical site visits.
  • Serves as a subject matter expert on cross-functional teams.
  • Contribute to and/or author clinical sections of regulatory documents including Investigators Brochure, DSUR, and responses to regulatory agencies and institutional review boards.
  • Author, review and revise MSA department Standard Operating Procedures.
  • Develop, implement and maintain clinical research training presentations, project management tools, trackers, logs, checklists, forms, and plans.
  • Attend relevant industry conferences and Aesculap events as a representative of MSA and present new knowledge and experiences at department meetings upon return.
  • Provide scientific support in the development of clinical study protocols, statistical analysis plans, data collections and data management strategies for clinical studies and other projects.
  • Generate scientific evidence for marketing collateral.
  • Oversee and maintain the centralized publication and scientific material repository of literature and knowledge gained pertaining to key products.
  • Register appropriate clinical studies on ClinicalTrials.gov and work with study team to update as necessary and in compliance with FDAAA 801 requirements.
  • Contribute to mentoring/coaching junior members of the Medical Scientific Affairs team.
  • Contribute to and participate in the development of high level clinical research training presentations used to educate the organization on the clinical research process.
  • Lead and/or participate in organizational and/or departmental process improvement committees.
  • Must comply with applicable ISO and FDA regulations as stated in Quality Manual
  • Must embody the Companys Vision, Mission and Values
  • Other duties may be assigned

Secondary or peripheral job functions:

  • The duties performed are generally of a confidential nature and require a thorough knowledge of practices and procedures of the function, company products, policies and programs.
  • Ability to work independently under minimal supervision.
  • Must be able to travel by air and car, and work occasional weekends.
  • Requires excellent written and interpersonal communication skills.
  • Ability to work with or use Personal Computer, printer, photocopier, facsimile machine, telephoneMust possess previous working knowledge of web based applications, Word, Excel, and PowerPoint. Experience with SAP and DataLabs is desireable.
  • This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.
  • Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
  • Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
  • Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices.

Supervisory Responsibilities:

  • Clinical Research Associates

Language and mathematical skills; reasoning ability:

Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.

Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.



Qualifications

xpertise: Qualifications - Experience/Training/Education/Etc

Required:

  • Bachelors Degree required or at least 10 years of related experience in working in clinical research utilizing established project management methodology.
  • Masters degree preferred
  • 3-5 years related experience required
  • 3-5 years management experience required
  • Project management certification preferred
  • Clinical research certification is (i.e., CCRP) preferred
  • Excellent interpersonal and communication skills, both written and verbal
  • Ability to work and manage effectively in a team environment
  • Highly organized with the ability to manage multiple projects at one time

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com

Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.



All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.



PI148287977

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Posted: 2021-09-29 Expires: 2021-10-30

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Scientific & Clincal Affairs Manager, Biologics

Aesculap Biologics
Breinigsville, PA 18031

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