Study Project Manager II

Initial Therapeutics, Inc.; California (MO); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

Initial Therapeutics, Inc. is seeking a Study Project Manager II in California to lead the operational delivery of clinical studies. The role requires a minimum of 8 years of experience in clinical research and strong leadership skills in managing cross-functional teams.

The position offers a hybrid schedule with onsite requirements on Tuesday, Wednesday, and Thursday. Ideal candidates will have expertise in clinical operations and a commitment to quality in overseeing clinical studies.

Qualifications

• Minimum 8 years of experience in clinical research study management.
• Demonstrated leadership in cross-functional team settings.
• Well versed in ICH/GCP regulations and AbbVie SOPs.

Responsibilities

• Drive operational delivery of clinical research studies.
• Lead cross-functional teams with minimal supervision.
• Manage vendor collaboration and oversight.

Skills

Clinical research study management

Leadership

Vendor management

Risk management

Coaching and mentoring

Strategic thinking

Education

Bachelor's Degree or equivalent

Tools

EDC

IRT

CTMS

eTMF

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Study Project Manager II drives the connection between the asset and operational delivery and execution of one or more clinical research studies. Leading the delivery of clinical operational strategies to ensure studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project Manager II achieves these objectives by bringing scientific acumen, strategic asset level thinking, innovation, expertise in clinical study operations management and stakeholder management to address risks and challenges. Contributor and leader in cross-functional teams and mentor/coach for team members.

This role is based in our Irvine, CA office location. Hybrid schedule and the onsite days are Tuesday, Wednesday and Thursday.

Responsibilities

• Strategic thinking: Ability to link asset level goals with study level operational strategies and deliverables. Uses strategic, asset level thinking in innovative problem solving. Effectively present and contribute to discussions on study operations at asset level strategic meetings.
• Commitment to Quality: Responsible for operational excellence in all aspects of oversight for clinical studies in compliance with ICH/GCP, Global Regulations, and AbbVie SOPs.
• Leadership: Demonstrates skills, experience and critical thinking to lead cross functional teams with minimal supervision; demonstrating expertise in end-to-end clinical study operations management (all phases, set up to close out) to drive milestone achievement.
• Study / System Management: For study planning, able to leverage understanding and expertise of Abbvie clinical study systems, and provide input on the development of the clinical study design and associated systems, tools and documents.
• Vendor Oversight: Provide oversight on collaboration with external partners including: vendor selection, scope development, contract review, SOW review/approval, data transfer planning and deliverable and timeline management.
• Risk Management: Using past experience and knowledge of quality standards, able to proactively identify risk, address and/or elevate study related issues; provide solutions and options to mitigate risk.
• Coaching: contributes to Specialized Clinical Operations culture of supporting growth; Coaches and mentors team members, delegates and empowers to the right level, shares lessons learned, best practices and influencing skills training.
• Innovation: Identify process improvements and lead changes for improvement of operational efficiencies supporting and fostering a culture of innovation.

Qualifications

• Bachelors Degree or equivalent degree is required.
• 8 years of demonstrated clinical research study management.
• Demonstrated leadership and experience with working with cross-functional internal teams.
• Experience in drug, device, interventional and non-interventional, early feasibility studies.
• Previous study management in end to end study operations, from study initiation through study completion in Phase 1-4 drug and/or device studies.
• Well versed in AbbVies SOPs (as well as ICH/GCP regulations).
• Expertise with Abbvie clinical trial systems (e.g., EDC, IRT, CTMS, eTMF).

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html