广州招聘

Position Description:

The Senior Clinical Research Specialist responsible for overseeing all clinical activities related to one or more clinical studies and performing/managing the daily field operations associated with support of the assigned studies. This position should be able to function with minimal supervision, handling various clinical study assignments, and collaborating with cross-functional colleagues in resolution of strategic and operational issues.

Position Responsibilities:

• Develop and execute clinical study specific strategies and operational plans.

• Assure successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies. This may involve multiple regulatory requirements, based on location of study conduct.

• Work collaboratively / lead study members from the Medtronic Clinical Research Institute

• Actively participate protocol writing and final report writing process.

• Provide oversight of monitoring activities and operations functions in assigned locales, as well as technical training/feedback to study site personnel and team members. Liaise to clinical sites, CRO and management, in-house Program Team, and U.S. Field Team or International Clinical Team (as applicable).

• Interface with cross-functional groups including R&D, Operations, Customer Service, Manufacturing, Sales, Software Development, Marketing, Regulatory Affairs, Legal, and Finance.

• Determine obstacles, identify solutions, and implement plans in collaboration with the study team to meet study objectives, scope, schedules and budget. Enlist support and specify tasks for various clinical and project team members to assure that study deliverables and timelines are met.

• Research, prepare and present study related information to management in a timely and proactive manner.

• Perform and oversee site the activation process. Participate in development of detailed training plans and materials; interface / train investigators, site staff, and CRO staff as applicable. Oversee set-up and maintenance of accurate study budgeting, status tracking and product accountability. Coordinate clinical activities based on site and study needs and perform other duties as assigned. Ensure adequate documentation and resolution of issues, This will usually involve oversight of CRO monitors, but may require hands-on intervention in cases.

• Collaborate with cross-functional team/CRO in evaluation of safety data, device reconciliation, and data analysis.

Basic Qualifications:

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

Education Required

· Bachelor’s degree, preferably in Sciences

Years of Experience

· 5 years’ work experience, with at least 2 years in a clinical setting

· Work Experience directly supporting clinical research or similar experience in a medical/scientific area

Specialized Knowledge or Skills Required

• 2 years’ Project Management experience in a clinical setting

Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation and reporting.

Desired/Preferred Qualifications:

• Preferred education in engineering, life sciences or related medical/scientific field. Advanced degree preferred (Masters, MD, or Ph.D), RN preferred

• Experience with Medical Device Industry Clinical Research

• Work Experience directly supporting clinical research or similar experience in a medical/scientific area

• Nursing/clinical work history preferred.

• Exposure to Clinical Operations.

• Demonstrated ability to work effectively on cross-functional teams. (Including R&D, Marketing, Operations)

• Experience interfacing with CRO teams.

• International clinical trial management experience.

• Ability to speak multiple languages

• CDE (certified diabetes educator) or CCRA certification (Certified Clinical Research Association) or equivalent preferred

• Proficiency with writing reports, business correspondence and procedure manuals

• Finance and budgeting knowledge.

• Knowledge of Diabetes

• Advanced computer literacy with MS Word, Excel and PowerPoint

• Advanced written and oral communications skills, with proficient knowledge of medical terminology.

• Ability to present complex technical products and processes to physicians in a clear, direct manner.

• High attention to detail and accuracy and ability to manage multiple tasks.

• Strong prioritization, organizational, and problem solving skills.

• Excellent interpersonal communication skills.

• Self-starter who is willing to work very independently and is self-directed

• Ability to work independently, with positive flexible outlook.

• Ability to present a professional manner and appearance.

• Experience with GCPs and regulatory compliance guidelines for clinical trials

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.

· While performing the duties of this job, the employee is regularly required to talk or hear, frequently required to sit and reach with hands and arms, and regularly required to stand; walk and use hands to finger, handle, or feel.

· Extended periods of time doing computer-based work

· Normal fast-paced office environment; requires use of telephone and significant use of computer keyboard, monitor, and mouse.

· The employee must frequently lift and/or move up to 25 pounds.

· Stand/sit 40 hours/week.

· May require working extended hours as required to meet reporting requirements.

· Candidates must be able to work flexible hours that may include working occasional weekends or evenings. · Ability to travel up to 25% of the time (including extended air travel)

ABOUT MEDTRONIC

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.

EEO STATEMENT

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

DISCLAIMER

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.

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.