Clinical Research Manager

Recruiter
Medtronic Inc.
Location
New Haven
Salary
Competitive
Posted
Oct 06, 2017
Closes
Oct 13, 2017
Industry
Healthcare
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Careers that Change Lives

Clinical Research professional with demonstrated project and personnel management skill set to provide leadership to Surgical Innovations GBU and personnel. Clinical Research Managers will work in a dynamic cross functional setting to drive medical device innovation and successful clinical study execution through product development oversight, medical affairs strategy assessment, standardized resource allocation, process improvement and personnel development.

The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Impact patient outcomes. Come for a job, stay for a career.

A Day in the Life

* Oversee the Global Clinical Strategy for a class of trade within the Surgical Innovations portfolio including related R&D projects in the pipeline; ensure that specific clinical plans and study protocols are consistent with the strategy

* Class of trade oversight to ensure patient safety, risk management, and compliance to SOPs, Quality System, Good Clinical Practice and applicable regulations for all Clinical Research activities

* Collaborate with Clinical Program Management to assure successful clinical strategy and study execution.

* Collaborate with Clinical Program Management during the development of Investigational Plans/protocols and other study documents to provide product portfolio strategic direction.

* Communicate the Clinical Strategy to all levels in the company, including Senior Leadership Team, R&D, Regulatory and Marketing groups.

* Serve as Clinical Research representative on business franchise and MDT Clinical Sub-Council team meetings

* May serve as department CAPA and Audit champion

* Collaborate with and serve as an escalation point for representatives from key cross-functional groups within an assigned Class of Trade

* Ensure successful conduct of GBU clinical programs consistent with R&D and Marketing plans and applicable regulations and policies.

* Manage Clinical Research participation in early product definition, planning, and product lifecycle management, including defining new markets and uses for Surgical Innovations products (Pre-PD)

* Maintain knowledge of competitive or state-of-the-art technologies and applicable regulatory requirements. Ensures that staff receives relevant training in applicable medical, technical, and biomedical training specific to their assigned business projects.

* Oversee Clinical Research review of training materials, external communications, and marketing collateral for current and future product lines.

* Responsible for building, developing and leading the Clinical Research function at one Medtronic location

* Recruit and retain talent.

* Manage staff objective setting, regular communication and feedback, development activities and appropriate reward and recognition programs

* Coordinate standardized resource assessment and allocation for all clinical activities in conjunction with Clinical Program Management team.

* Comply and interface with applicable FDA and international regulatory laws / standards and the Covidien Code of Conduct.

* Coordinate process improvement initiatives, taskforces, and committees within Clinical Research and cross-functionally.

* Reviews clinical protocols, clinical reports, Medical Affairs Strategies, and Clinical Evaluation Reports as needed

* Reviews clinical documents for regulatory submissions (FDA, Competent authorities, Notified bodies, IRBs, ECs, etc.) as needed

* May author and implement departmental policies and procedures in order to maintain clinical compliance at sites and internally.

* May lead internal governance councils

* May lead department led initiatives with a cross functional component

* May manage site specific department cost center

Must Have: Minimum Requirements

* Bachelor's degree in a health, medical, clinical sciences or technical field, (e.g. engineering, physiology, nursing, biomedical sciences)

* Six (6) or more years of experience in clinical research, medical, pharmaceutical, medical device or CRO setting or five (5) years of experience with Master's degree.

* Five plus years direct personnel management or equivalent management experience preferred.

* Has prior participation in product development and all facets of clinical study development and execution, with both US and international trials preferred.

Nice to Have:

* Is a positive, self-motivated, creative, detail-oriented team player with cross-cultural awareness.

* Demonstrate professional and leadership attributes throughout Clinical Affairs, cross-functionally, and with external customers.

* Adaptable and action-oriented in prioritization of project assignments in a rapidly changing complex medical device environment, able to project future trends and issues.

* Able to develop employees, build strong teams in a dynamic setting, and promote teamwork.

* Able to be process-oriented and strategic in approach to analyzing issues, problem-solving, generating new ideas, and improving efficiency.

* Able to build trust and confidence with direct reports and across functions to ensure open communication and ability to provide constructive feedback.

* Has expertise in applying different standards related to medical devices/ clinical research (SOPs, ISO, ICH /GCP, FDA, MedDev, etc.)

* Able to strategically and effectively communicate with cross-functional colleagues, internal leadership, and external professionals.

* Knowledge of clinical outcomes and research study design, methods, and statistics.

* Able to gain and share knowledge regarding changing industry trends.

* Demonstrates Ethics and Integrity

* Possesses high level organizational, interpersonal, and critical thinking skills.

* Differentiates the most appropriate mode of communication by situation type.

* Is strongly motivated, achieves work goals, and effectively executes through formal channels.

* Demonstrates initiative, good judgment, and decisiveness.

* Able to work with a minimum of supervision.

* Able to work in a highly matrixed team environment.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life 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.

EEO

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:

SDL2017