Edc Project Manager Jobs in Simi Valley, CA (NOW HIRING)

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

Responsibilities

• Design, develop, document, test and/ or support clinical study databases and configuration of cross-system interfaces per business process
• May support the design, development, testing, and/or maintenance of Clinical Reports, Clinical Data Transfers or other components related to clinical studies.
• Understand industry standards and apply them
• Partner as clinical technical specialists in the planning, designing, and implementing of clinical applications
• Provide technical consultation on and task direction for vendors
• Mentor more junior team members
• Project Management tasks, such as time management, manage budget, manage milestones, communicate progress, resolve issues
• Stay current on technologies, methods, standards, and best practices as well as trends and direction of the clinical data management industry
• Review and acknowledge all Standard Operating Procedures and other quality requirements assigned to the job role.
• Clinical database systems knowledge: advanced level of proficiency with clinical electronic data capture (EDC) systems, such as Medidata Rave and or other (Veeva EDC or Oracle EDC or other smaller systems) and clinical trial management systems.
• Expertise with SQL and advanced query development and complex queries.
• Build interface between clinical systems, experience in building rest APIs to import / export data from clinical systems.

SPECIALIST CAREER STREAM:

• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Required:

• Must have big-picture and detail-oriented view of development processes, tools and procedures.
• Clinical database systems knowledge: advanced level of proficiency with clinical electronic data capture (EDC) systems, such as Medidata Rave and or other (Veeva EDC or Oracle EDC or other smaller systems) and clinical trial management systems.
• Expertise with SQL and advanced query development and complex queries.
• Build interface between clinical systems, experience in building rest APIs to import / export data from clinical systems.
• Expertise with SQL and advanced query development. Custom Function program in Rave is a plus.
• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with 2 years of experience.

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Nice to Have:

DIFFERENTIATING FACTORS

• Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects /assignments.

Organizational Impact:

• Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity:

• Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area

Communication and Influence:

• Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

Leadership and Talent Management:

• May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

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 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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

For roleslocatedin California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $164,000.00- $221,000.00USD.

Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits informationpertainssolely to candidates hired within the United States (local market compensation and benefits will apply for others).

At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that "regular employees" refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.

For further details about our comprehensive benefits, we encourage you to visit the link below.

MiniMed Benefits Overview

MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey - when and how they need it. For more than 40 years, we've been committed to redefining what's possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it's needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.

Learn more about our business, and our mission here.

It is the policy of MiniMed 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, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for MiniMed in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. MiniMed will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.