"Alerted.org

Job Description

We are seeking a dynamic Project Manager/Business Analyst to lead digital transformation initiatives across Clinical Development Operations (CDO) and Program & Portfolio Management (PPM). This role combines strategic project leadership with deep business analysis, driving operational excellence and compliance in a fast-paced, regulated environment.

Key Responsibilities:

- Lead and deliver digital transformation projects within CDO and PPM.

- Develop and manage project plans, timelines, and deliverables aligned with organizational and regulatory goals.

- Facilitate cross-functional meetings, workshops, and reviews.

- Collaborate with internal teams and external vendors to ensure timely, on-budget delivery.

- Monitor progress, mitigate risks, and drive successful execution.

- Analyze and document business requirements and workflows specific to CDO and PPM.

- Translate business needs into functional and technical specifications.

- Ensure solutions meet pharmaceutical industry standards and regulatory requirements.

- Oversee IT security, data privacy, and risk assessments.

- Maintain audit-ready documentation and ensure compliance with IT infrastructure standards.

- Track and report project status, risks, and mitigation plans to leadership.

- Manage budgeting, forecasting, and cost tracking in collaboration with finance teams.

- Identify opportunities to optimize systems, infrastructure, and processes.

- Support change management to ensure successful adoption of new solutions.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

- Master's Degree in Life Sciences, Computer Sicence, or related field

- PMP Certification

- 5+ years in project management and business analysis within pharmaceutical R&D IT DevOps environments managing projects related to Clinical Development Operations and Program & Portfolio Management

- Proficiency with clinical trial technologies, including Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), eTMF, eCOA/ePRO/eConsent platforms, and Interactive Response Technologies (IRT); experience with tools such as Medidata, Oracle Siebel, Veeva Vault, Suvoda, and Inform preferred.

- Familiarity with advanced data and analytics platforms, including Risk-Based Quality Management (RBQM) tools (e.g., Medidata Detect, CluePoints), AI/ML-driven analytics, and data standards for integration and interoperability (e.g., CDISC CDASH, SDTM, ADaM; HL7/FHIR).

- Experience with portfolio and project management tools, such as Planisware, Microsoft Project Online, and Clarity PPM

- Skilled in business analysis techniques and documentation best practices null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].