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Manager, Clinical Operations
at Aesculap Biologics
Breinigsville, PA

Manager, Clinical Operations
at Aesculap Biologics
Breinigsville, PA

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Description

Aesculap Biologics


Manager, Clinical Operations

US-PA-Breinigsville

Job ID: 2019-14869
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, Clinical Operations 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, timelines, and budgets accordingly. This position drives the successful execution of assigned clinical studies/projects, ensures all study/project deliverables are met according to timeline budget, and resource requirements, and identify and address challenges in a collaborative team environment.

Responsibilities: Essential Duties

  • Oversee 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 selection/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.
  • Work closely with the Manager, Scientific and Clinical Affairs in the management of clinical monitoring, safety and data management, and the biostatistics aspects of clinical studies.
  • Negotiate agreements/budgets with clinical sites, consultants, and vendors in collaboration with legal and compliance departments as they relate to clinical studies and projects.
  • Oversee clinical site budgets and payments per contract
  • Manage and set annual goals, objectives and development plans for clinical research and contract coordinator positions, provide performance evaluations and feedback.
  • Facilitate study meetings, including investigator meetings, and study training as necessary, as well as attend surgeon trainings and site visits as necessary.
  • Serve as a subject matter expert; lead and/or participate on cross-functional teams.
  • Contribute to and/or author clinical sections of regulatory documents including Investigator’s Brochure, DSUR, and responses to regulatory agencies and institutional review boards.
  • Author, review and revise Medical Scientific Affairs department Standard Operating Procedures, as well as Chair the MSA Best Practices Committee.
  • Develop, implement and maintain clinical research training presentations, project management tools, 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.
  • Must comply with applicable ISO and FDA regulations as stated in Quality Manual
  • Must embody the Company’s Vision, Mission and Values
  • Other duties may be assigned
  • Secondary or peripheral job functions:
  • 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.
  • Clinical Research Associates will report to this position.

Expertise: Knowledge & Skills

  • 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

Expertise: Qualifications-Experience/Training/Education/Etc


Required:

  • Bachelors degree in medical, life and/or health sciences and 5-7 years of experience working in clinical research utilizing established project management methodology.
  • Must have clinical research certification or health science license (e.g., CCRP, RN).
  • Previous work experience within the clinical research process (i.e. study management and/or clinical monitoring) is required.
  • Previous line management experience in a clinical research environment is required.
  • Thorough knowledge and understanding of ICH-GCP, Code of Federal Regulations, HIPAA, and all other relevant regulations for the conduct of clincial trials.
  • 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.
  • 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, telephone.
  • Must possess previous working knowledge of web based applications, Word, Excel, and PowerPoint. Experience with SAP is desireable.

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.


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