Project Manager Clinical Research Ii

3+ years

86,700.00 – $173,300.00

Alameda

10 March 3, 2025

Job Description

Job Type: Full Time Education: B.E./B.Tech/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Project Manager Clinical Research II

Location: United States - California - Alameda
Category: Medical and Clinical Affairs

About Abbott:
Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life. Our portfolio includes life-changing technologies spanning diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues, we serve people in more than 160 countries.

Job Title:
Senior Specialist Project Management

Working at Abbott:
At Abbott, you will have the opportunity to work on meaningful projects, grow and develop your career, and enjoy excellent benefits, including:

Career development in an international company with limitless growth opportunities.
Free medical coverage under the Health Investment Plan (HIP) PPO.
A strong retirement savings plan with high employer contributions.
Tuition reimbursement, student debt assistance, and FreeU education benefits.
Recognition as a top workplace worldwide, including accolades for diversity, working mothers, female executives, and scientists.

The Opportunity:
The Clinical Manager is responsible for managing and meeting the objectives of Systems clinical projects, including project management of a diverse portfolio, global strategic priorities, building studies in the EDC system, gaining expertise in various systems, and New Technology Assessments (NTA). This position is onsite Monday-Friday at our Alameda, CA office.

Responsibilities:

Manage systems teams, including tracking and coordination of strategic projects, database builds, laptop allocations, and testing of new technology solutions.
Develop the NTA or applicable project plan in consultation with the cross-functional project team and clinical team.
Present project plans, provide updates, and share results with senior clinical management.
Assist in managing and executing the NTA and/or applicable clinical projects.
Ensure all Division staff are trained on the project requirements.
Maintain "audit-ready" clinical projects at all times.
Conduct clinical visits as needed to support NTA and/or clinical projects.
Oversee safety concerns, adverse events, and trends in field event reporting.
Provide clinical input for planning post-project activities and market launches.
Author or co-author project results in medical literature and present findings at scientific meetings.
Monitor project reports for accuracy and trends, and provide input on budgets and plans.
Evaluate clinical data for study summary reports and regulatory submissions.
Develop and implement corrective actions for compliance issues.
Review marketing materials related to NTA or clinical projects.
Support divisional initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory compliance.

Required Qualifications:

Bachelor's degree in Engineering, Biological Sciences, or a related medical/scientific field.
Master's or Doctorate degree preferred.
Minimum of 3 years of experience in clinical research or a similar medical/scientific role.
1-3 years of experience managing projects and working with clinical professionals in a cross-functional setting.

Preferred Qualifications:

Strong project management skills and ability to track goals using system tools.
High attention to detail and accuracy.
Excellent written and oral communication skills.
Ability to manage multiple tasks efficiently.
Proficient knowledge of medical terminology.
Expertise in Good Clinical Practices (GCPs) and regulatory compliance guidelines (ISO Standards, FDA).
Strong problem-solving skills and knowledge of clinical research study design.
Advanced computer skills and the ability to work in cross-functional teams.
Ability to travel as needed (<25%).

Apply Now:
Learn more about our health and wellness benefits at: www.abbottbenefits.com.

Follow your career aspirations with Abbott, a company committed to diversity and employee growth.

Connect with us at:

Website: www.abbott.com
Facebook: www.facebook.com/Abbott
Twitter: @AbbottNews

Divisional Information:
Medical Devices: Our devices help over 10,000 people maintain heart health, improve quality of life for individuals with chronic pain and movement disorders, and assist over 500,000 people with diabetes management.

Diabetes Care: We focus on improving diabetes management with innovative products that provide accurate data for better decision-making. Our sensing technology is revolutionizing glucose monitoring.

Compensation:
The base pay for this position is $86,700.00 – $173,300.00, with variations based on location.

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Project Manager Clinical Research Ii

Job Description

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