Direct Portfolio Project Manager (Record and Retention) — Pharmaceutical (Onsite – Indianapolis, IN) Contract

Overview:

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Our Fortune 500 Pharmaceutical client has an exciting opportunity for Direct Portfolio Project Managers.

Job Summary:

We are seeking experienced Direct Portfolio Project Managers to support a project with one of our clients in their Clinical Trials Patient Engagement Team, driving innovative strategies to enhance patient involvement in research. This role plays a critical part in optimizing clinical trial recruitment, retention, and overall project management. The ideal candidates will have a strong understanding of clinical trial processes, protocols, and regulatory best practices, combined with expertise in project management.

We have two (2) open positions, specializing in Record & Retention.

Key Responsibilities:

• Recruitment & Retention Strategy: Develop and implement strategies to enhance patient recruitment and retention for clinical trials and programs.  
• Project Management Oversight: Provide leadership in managing trial-related projects, ensuring efficiency, compliance, and adherence to regulatory requirements. 
• Cross-Functional Collaboration: Work closely with internal teams and stakeholders to streamline clinical processes and improve trial outcomes. 
• Record & Retention Compliance: Support documentation management and ensure compliance with clinical trial record-keeping requirements. 

Qualifications:

·       7 years required (5 years minimum) in Clinical Trial Documentation, including TMF, ISF, IRB submissions, and regulatory documentation.

·       Clinical trial oversight experience, ensuring compliance with FDA, ICH-GCP, and regulatory best practices.

·       Hands-on experience managing TMF, ISF regulatory compliance documentation, including audit readiness, submissions, and quality control.

·       Located within commuting distance to Indianapolis for fully onsite work.

Other Details:

·       Schedule: Full time, 40 hours per week

·       Contract Length: 18 months with renewal

·       Work Setup: Indianapolis, IN

·       Resources Needed: 2

In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.

EEO Employer:

Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com.

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.

E-Verify Participation:

Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.