Associate Clinical Project Manager

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.You'llalso have access to:

Career development with an international company where you can grow the career you dream of

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with high employer contribution

Tuition reimbursement, theFreedom 2 Savestudent debtprogramandFreeUeducation benefit - an affordable and convenient path to getting a bachelor's degree

A company recognized asa great placeto work in dozens of countries around the world and named one of the most admired companies in the world by Fortune

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

For years, Abbott's medical devicebusinesses have offered technologies that are faster, more effective, and less invasive. Whetherit'sglucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than10,000 peoplehave healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than500,000 peoplewith diabetes from routinengersticks.

The Opportunity

Will berequiredto manage at least one primary project; Depending on scope and phase of project, may support multiple projects.

Provides project managementexpertisethroughout the development and implementation of clinical studies. Interacts with various study support groups and the business unitin order toassistin clinical strategy, the development of study plans, and project deliverables.

Is also assigned to other non-trial related activities such as process and procedure teams.

May support and mentor junior-level project managers.

Facilitatescommunication between R&D, Regulatory Affairs, Sales and Marketing, Training, SeniorManagementand investigational sites by conducting team meetings,draftingand sending routine correspondence (e.g., newsletters) and by presenting regular updates tomgmtstaff.

Facilitatessite selection process by conducting meetings withappropriate departmentsand individuals to review and revise draft site list as necessary, and by communicating the final site list to team members.

Manages clinical study timelines, budget byutilizingtheappropriate projectmanagement tools, selecting providers, managing vendorcontractsand ensuring expenditures are within budgetary guidelines.

Identifyresource needs and elevates/resolvesresource constraints with mgmt.

Facilitatesregulatory submissions and communications by communicating with Regulatory Affairs during the submission process.

Facilitatesthe development of clinical strategy and trial design by conducting meetings with theappropriate departmentsand individuals to obtain feedback/direction.

Provides input to protocol design, case report form design, data management plan,monitoringplan.

Organizes Steering Committee meetings and communication; Coordinates investigator and research coordinator meetings.

Oversees compliance to study requirements; Reviews compliance to protocol and elevates critical protocol deviations

Works with Study Team to coordinate activities for all milestones; database locks, annual reports,presentationand publications

Provides study-specific training to internal team members and site personnel.

Required Qualifications

• BachelorsDegree ( 16 years), Preferably in Life Sciences ORan equivalent combination of education and work experience

• Minimum 5 years,Medicaldevices, clinical research experience, or related industry. Prefer at least 3 yearsof relatedwork experience in Quality role in medical device area and/or clinical trial environment. PreferGCP auditexperience.

• Specific requirements: Fluent in English, anyadditionalmajor language is a preferred asset; Excellent Communicator; Computer Literate.

Preferred Qualifications

Exercises authority and judgment to determineappropriate action.

Demonstratesdiplomacy and respect for others. Acts as a buffer for the team, providing focus andappropriate prioritization. Facilitates decision making.

Demonstratesabilityto influence others to achieve positive results and collaboration.

Excellent knowledge of ISO and local regulations andrequiredfor clinical trials. Proven record of compliance with, and enforcement of, regulations in clinical trials.

Sets quality and compliance goals for the trial and monitors/manages compliance as part of clinical project management.

Developsadditionalproject management tools to improve clinical trial performance.