B. Braun

Clinical Trial Manager

Job Locations US-PA-Allentown
Requisition ID
2021-18081
Company
B. Braun Medical Inc
# of Openings
1
Category
Regulatory
Position Type
Regular Full-Time
Shift
8:00 AM - 4:30 PM
Site
Allentown, PA

Overview

About B. Braun 

 

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.

 

Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.

Responsibilities

 

Position Summary:

 

The position of Manager drives the successful execution of assigned clinical, pre-clinical and non-clinical, (eg simulated use) studies for both pharmaceutical and/or medical device products using strong management and organizational skills, oversees the studies progress and addresses and manages obstacles, serves as a primary contact for the studies, coordinates the development of the protocol and prepares all required documents and plans, and manages all aspects of clinical trials from site qualification to close-out with minimal supervision and according to GCP/ICH guidelines and FDA regulations. Assists with study pharmacovigilance and provides input to regulatory affairs on study implications and outcomes as an ad hoc team member.  This work is done in support of Regulatory requirements, registration, and marketing needs and claims. Manager and Sr. Managers are expected to demonstrate a high degree of responsibility, accountability, and independence in the performance of these duties.

 

Responsibilities: Essential Duties

  • Drives the successful execution of assigned clinical and simulated use studies for Braun pharmaceutical and medical device products.
  • Responsible for protocol development and study design, manages the progress of the study, and serves as a primary contact with Clinical Research Organizations (CRO), Principal Investigators (PI), and
  • Plans and manages all aspects of the conduct of clinical trials, from site qualification to close out and reporting, in accordance with GCP/ICH guidelines and other FDA applicable
  • Responsible for project management of all assigned clinical and simulated studies sponsored by Braun.

Knowledge and Skills Requirements:

  • Requires advanced knowledge of professional field and industry.
  • Influences the development of and drives the application of principles, theories, concepts.
  • Determines best course of action.
  • Knowledge of medical terminology and application of scientific/medical and clinical concepts used to conduct clinical trials is required.
  • Must have skills and experience in medical writing
  • Effectively communicate with all levels within the organization.
  • Publications: Generate and/or review of scientific publications as required.
  • Ability to design / revise clinical study documents and work with outside contractors as well as internal departments to execute clinical protocols.
  • Highly-self-motivated, able to work effectively with minimum supervision, able to adapt to changes, and maintain a high level of performance.

Desired:

  • Degree in healthcare related regulatory or clinical discipline, nursing degree (RN), or pharmacy degree is preferred.
  • Clinical study management experience in both pharmaceutical and device trials in a sponsor setting is preferred.

 

 

Supervision Given and Received:
Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.

 

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

 

General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required.
  • 08-10 years related experience required.
  • Occasional business travel required

 

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.

 

Other

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

While performing the duties of this job, the employee is expected to:

 

Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

 

Lifting, Carrying, Pushing, Pulling and Reaching:

 

Occasionally:Reaching upward and downward, Push/pull, Stand

Frequently: Sit

Constantly: N/A

 

Activities:

 

Occasionally: Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking

Frequently: Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick

Constantly: N/A

 

Environmental Conditions:

 

Occasionally: N/A

Frequently: N/A

Constantly: N/A

 

Work Environment:

 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Noise Intensity: Moderate

Occasionally: Other

Frequently: N/A
Constantly: Office environment

Notices

Equal Opportunity Employer Veterans/Disabled

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