Clinical Study Manager / 2642 Job in Breinigsville 18031, Pennsylvania US

Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparascopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania.

Position Description:

Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, spine, laparoscopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania. Aesculap, Inc., has an excellent opportunity for a Clinical Study Manager.

SUMMARY:

Responsible for the management, administration, and organization of the trial team, including providing leadership, study specific training, coaching and mentoring of the trial staff. Clinical studies at Aesculap include drug/biologics; device; and investigator initiated studies. Demonstrated experience across study types is preferred.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Clinical trial design with stakeholder input such as: medics, KOLs, product managers, medical advisors, etc.
• Prepare and facilitates the review of case report forms, protocols, instructions for use, study operations manuals, site and annual reports.
• Develops and maintains relationships with outside consultants and vendors as required for each protocol and study execution.
• Reviews and approves study budgets within the established guidelines, provides initial review of study contracts for changes.
• Estimates product needs with management approval, initiates supply management process.
• Assists in preparation of regulatory submissions.
• Interfaces externally with clinical investigators, investigational sites and project vendors.
• Anticipates, recognizes and resolves issues that many have impact on compliance or project deliverables.
• Mentors Clinical Coordinator and Clinical Specialists to enhance understanding of the clinical study processes and study conduct.
• Creates and manages timelines for milestone deliverables.
• Reviews proposals, contracts and budgets with consultation of internal team.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Must have good working knowledge of appropriate guidelines, policies and practice specific to trial experience. Examples include: Good Clinical Practice (GCP), ICH, CFR, and/or ISO 14155 requirements. Applicant should understand clinical operational requirements under GMP and/or GTP regulations as appropriate to type of product (device, biologic/drug).
• Prepares, organizes and presents at internal and external meetings.
• Develops and contributes to internal and external training and communication programs
• Other duties may be assigned.

OTHER DUTIES AND RESPONSIBILITIES:

• Must be able to travel (automobile and air transport).
• Must be able to occasionally travel on weekends
• Ability to work with or use Personal Computer, printer, photocopier, facsimile machine, telephone, Microsoft products, SAP desirable, Lotus Notes
• This position may be exposed to potentially contaminated instruments and 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.

SUPERVISORY RESPONSIBILITIES:

Carries out management responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION/EXPERIENCE:

• Bachelor’s degree in biological sciences or nursing; Master’s degree a plus.
• 9-15 years experience in clinical research. 5 years managerial experience.
• Excellent interpersonal skills and the ability to work and manage effectively in a team environment.
• Highly organized with the ability to manage complex projects.

LANGUAGE AND MATHEMATICAL SKILLS; REASONING ABILITY:

Language Skill: Ability to read, analyze, and interpret common scientific, medical and spine 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, sales force, surgeons, 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 deal with multiple problems at one time.

PHYSICAL DEMANDS:

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

Note: Physical demands in this section may vary by job title, name all that apply to the specific job.
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 finger, 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.

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.

The noise level in the work environment is usually moderate.

Aesculap offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension and tuition reimbursement. To learn more about Aesculap and our products, please visit us on the internet at www.aesculapimplantsystems.com . EOE/AA.