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External Research Program Enterprise Manager

MemphisMedtronic



POSITION DESCRIPTION:

This role serves as a member of the MC2 Global Clinical Study Administration Organization and supports the external research program system across Medtronic. The External Research Program Enterprise Manager will be the subject matter expert for Vision Tracker. He/she will work closely with Medtronic Clinical Affairs, Global IT and applicable vendors. The core responsibilities may include, user support, evaluation of user's current needs, business requirements gathering, and helping to implement new solutions as necessary. The successful candidate will have a commitment to delivering the highest quality work, a strong sense of task ownership, a global vision, and the ability to excel in a fast-paced and team-oriented environment. This position will require occasional travel.

POSITION RESPONSIBILITIES:

  • Subject matter expert for Vision Tracker & external research programs

  • Manage the External Research Program Enterprise Team

  • Administration of Vision Tracker including data entry for new requests

  • Super user with access to all external research programs

  • Point of contact when applications are routed incorrectly to business units

  • Manage Vision Tracker users (disable users as needed)

  • Perform user acceptace testing during configuration cycles

  • Own and monitor external research program Medtronic email box

  • Support ~700 users

  • Escalation point for business unit subject matter experts for questions

  • Maintain process documents

  • Perform quality checks

  • Generate portfolio report

  • Lead circle of excellence

  • Maintain circle of excellence sharepoint site

  • Provide updates to clinical council (metrics)

  • CAPA owner for systemic findings

  • Provide user support, troubleshoot and track system-related issues

  • Coach direct reports, create attainable objectives and goals to encourage talent development

  • Develop, evaluate and revise process documents, including but not limited to standard operating procedures to ensure system and user compliance

  • Proficient understanding of business process management and requirements for Clinical Affairs translating into specific system enhancement requirements

  • Collaborate with Clinical Affairs, Global IT, and vendors to gather business requirements for new solutions and system integrations as necessary

  • Business representative for the implementation for Vision Tracker system point releases

  • Implement and deliver system level trainings to ensure user compliance

  • Provide detailed ad-hoc user guidance while delivering superior customer service

  • Keep abreast of available industry clinical solutions to ensure Medtronic remains competitive

  • Collaborate with Medtronic Clinical Affairs globally to improve processes and implement best practices

  • Participate in staff meetings and team meetings as required

  • Develop understanding of general industry usage of supported technologies

  • Develop understanding of business processes and business dependencies on supported technologies

  • Develop relationships with Global IT and with supported customers to improve upon the collaboration and teamwork necessary to accomplish organizational objectives

  • Any additional duties assigned with or without notice

    IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME

    BASIC QUALIFICATIONS:

  • Bachelor's Degree

  • 6+ years experience supporting clinical systems

  • Experience developing and implementing process documents and trainings

    DESIRED/PREFERRED QUALIFICATIONS:

  • Knowledge of ICH/GCP/FDA regulations and guidelines as they pertain to clinical systems

  • Proficient understanding of Clinical Affairs business processes

  • Knowledge of systems development life cycle and relational databases

  • Experience with Microsoft Office products (e.g. Word, Excel, Access)

  • Demonstrated knowledge in a clinical area

  • Ability to present in front of colleagues and upper management

  • Attention to detail and accuracy

  • Ability to manage and prioritize multiple tasks

  • Effectively work independently and in a team setting

  • Knowledge of clinical and outcomes research study and a general understanding of clinical process, regulations and regulatory standards

  • Familiarity with GCP and regulatory and compliance guidelines for clinical trials

  • Problem-solving skills

  • Strong written and verbal communication skills

    PHYSICAL JOB REQUIREMENTS:

  • The physical demands described within the Responsibilities section of this job description 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.

  • While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

  • Ability to travel 10-20% of the time

    MEDTRONIC OVERVIEW:

    Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

    We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

    It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

    This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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