Sr. Manager, Integrated Clinical Trial Data Process

USDM Life Sciences; United States; Remote; USD 96,000 - 110,000; Full time

Job summary

USDM Life Sciences is seeking a Sr. Manager, Integrated Clinical Trial Data Process to lead process development for CTD and Pharmacovigilance initiatives. The role emphasizes creating process maps, RACIs, procedures, and job aids, in partnership with accountable Takeda stakeholders who own governance and final approvals.

The candidate will facilitate cross-functional workshops, document requirements, and maintain project plans and risk logs in a global, remote setting.

Qualifications

• Operational experience in Clinical Operations, Study Management, Data Management, and/or Pharmacovigilance.
• Working knowledge of GxP quality systems and ICH GCP.
• Experience translating complex operational requirements into process maps and related content.

Responsibilities

• Partner with stakeholders to execute process-development for CTD and PV initiatives.
• Create and update Lucid process maps using approved requirements and stakeholder input.
• Facilitate cross-functional workshops and SME interviews to gather requirements and clarify roles.
• Draft and revise process documentation per quality and document-control requirements.
• Coordinate PleaseReview workflows and maintain review records.
• Maintain project plans, RAID logs, and deliverable trackers for initiatives.
• Identify risks, dependencies, decisions, and next steps for initiatives.
• Provide recommendations within scope and escalate as needed.

Skills

Clinical Operations

Study Management

Data Management

Pharmacovigilance

GxP quality systems

ICH GCP

Cross-functional facilitation

Process mapping

Education

Bachelor’s degree

International equivalent

Tools

Lucid

Document-review workflows

Job description

Job Title: Sr. Manager, Integrated Clinical Trial Data Process

Job Function: Subject Matter Expert

Location: Remote

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

This role provides process-development expertise and operational delivery support for Clinical Trial Delivery and Pharmacovigilance initiatives, including developing process maps, RACIs, procedures, work instructions, job aids, and related implementation materials based on approved requirements and stakeholder input. It involves facilitating workshops, stakeholder interviews, documentation activities, and project tracking to support effective and compliant ways of working, all in partnership with accountable Takeda stakeholders, who retain process ownership, prioritization, governance, decision-making, and final approval responsibilities.

Primary Responsibilities

• Partner with accountable stakeholders to execute assigned process-development and improvement activities for CTD and PV initiatives.
• Develop process content packages, including process maps, RACIs, procedures, work instructions, job aids, implementation materials, and other supporting documentation, as applicable.
• Create and update Lucid process maps using approved requirements, existing documentation, and stakeholder input.
• Facilitate cross-functional workshops and subject matter expert interviews to gather requirements, document process steps, clarify roles and handoffs, and confirm proposed content.
• Draft and revise process documentation with document owners and subject matter experts in accordance with applicable quality and document-control requirements.
• Coordinate activities for assigned PleaseReview workflows, including preparation of review packages, tracking comments, scheduling comment-reconciliation discussions, and maintaining review records.
• Maintain project plans, status reports, action and decision logs, RAID logs, and deliverable trackers for assigned initiatives.
• Identify and document risks, dependencies, unresolved questions, and required decisions for assigned initiatives.
• Provide process-development expertise and recommendations within the assigned scope, escalating prioritization needs, complex decisions, governance matters, and items requiring final approval to accountable stakeholders.

Additional Responsibilities

• Performs other related duties and assignments as required

Qualifications

• Operational experience in Clinical Operations, Study Management, Data Management, and/or Pharmacovigilance; Global Regulatory Affairs experience is beneficial but not required.
• Demonstrated experience translating complex operational requirements and existing documentation into clear process maps, RACIs, procedures, work instructions, job aids, and related process content.
• Working knowledge of GxP quality systems, controlled-document practices, clinical trial and/or PV processes, and applicable regulatory expectations, including ICH GCP.
• Experience facilitating cross-functional workshops and subject matter expert discussions to gather requirements, clarify roles and handoffs, and confirm proposed process content.
• Ability to independently develop assigned deliverables within agreed requirements and scope.
• Experience with process-mapping tools such as Lucid and document-review workflows.

Additional Qualifications

• Six or more years of relevant experience in the pharmaceutical industry, biotechnology industry, or a clinical research organization.
• Strong written and verbal communication, organization, facilitation, interpersonal, conflict-resolution, and problem-solving skills.
• Demonstrated ability to collaborate effectively in a global, cross-functional, and matrixed environment.
• Ability to organize and manage multiple assigned deliverables, meet agreed timelines, and provide clear and timely status updates.
• Ability to adapt to changing priorities, incorporate stakeholder feedback, and work independently within established scope and direction.
• Global or international experience preferred, including the ability to collaborate with stakeholders across locations and time zones.

Education & Certifications

• Bachelor’s degree or international equivalent required; degree in life sciences or a related discipline preferred.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 70.00 - 80.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.