Project Manager - Ampcus Incorporated

Jersey City, NJ

About the Job

Bravens Inc., a wholly owned subsidiary of Ampcus Inc., is an information technology consulting and services company. Bravens is a leader in providing tailored staffing solutions across both IT and non-IT industries. We are in search of a highly motivated candidate to join our talented team and contribute to our ongoing success.

Job Title: Project Manager

Location(s): Jersey City NJ (Remote )

Must have: Electronic Clinical Outcome Assessments (eCOA) and Digital Clinical Trials (DCT)

Job Description:
We are seeking a highly skilled and motivated Project Manager with specialized experience in electronic Clinical Outcome Assessments (eCOA) and Digital Clinical Trials (DCT) to lead and manage the delivery of clinical trials with innovative, patient-centered solutions.

Lead and manage all aspects of the eCOA and DCT project lifecycle, from initiation through to completion, ensuring alignment with scope, timeline, budget, and quality standards.
Work closely with internal teams (clinical operations, data management, regulatory, medical affairs, etc.) and external vendors (eCOA, DCT technology providers, CROs) to ensure seamless execution of projects.Act as the primary point of contact for all project-related communications.
Collaborate with clinical teams to incorporate eCOA and DCT solutions into clinical trial designs, ensuring regulatory and compliance requirements are met.
Provide expert guidance on the selection and integration of appropriate eCOA tools and digital technologies for patient data collection, monitoring, and reporting.
Oversee vendor relationships, including negotiation, contract management, and performance monitoring.
Develop detailed project timelines, tracking progress, and mitigating risks that may impact study timelines and costs.
Proactively identify project risks (e.g., technical, regulatory, operational) and develop mitigation strategies.
Resolve issues and escalate as needed to ensure project milestones are achieved.
Ensure that all project activities are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and other relevant global regulatory requirements.
Prepare and present regular project status updates to stakeholders, including senior leadership.
Maintain detailed project documentation and deliverables to ensure traceability and compliance.
Participate in post-project reviews and lessons learned to drive continuous improvement in project management processes and digital solutions implementation.

Required Skills and Qualifications:

Experience:
- Minimum of 3-5 years of project management experience in the pharmaceutical, biotechnology, or clinical research industry.
- Strong experience in managing clinical trials utilizing eCOA systems (e.g., ePRO, eConsent, and other electronic data capture solutions).
- Proven expertise in managing Digital Clinical Trials (DCT), including the use of remote monitoring, telemedicine, wearable devices, and patient-centric solutions.
Technical Knowledge:
- Strong understanding of eCOA platforms, clinical trial management systems (CTMS), and data management systems.
- Familiarity with digital trial technologies (e.g., wearables, telemedicine tools, mobile apps) and remote patient monitoring platforms.
- Knowledge of regulatory requirements for eCOA and DCT, such as 21 CFR Part 11, ICH E6, and HIPAA compliance.
Project Management Expertise:
- Excellent project management skills, including scope definition, budgeting, timeline management, and risk assessment.
- PMP (Project Management Professional) or other relevant certifications preferred.
- Ability to manage multiple projects simultaneously while meeting deadlines and maintaining quality standards.
Communication & Leadership:
- Strong communication, presentation, and interpersonal skills, with the ability to influence and engage stakeholders at all levels.
- Proven leadership skills with the ability to manage cross-functional teams and external vendors effectively.
Problem Solving & Analytical Thinking:
- Strong problem-solving abilities, with a proactive approach to identifying and resolving issues.
- Ability to analyze complex data and provide actionable insights to stakeholders.
Education:
- A Bachelor’s degree in Life Sciences, Clinical Research, or a related field is required.
- A Master’s degree or relevant certifications (e.g., Clinical Research Coordinator, Clinical Research Associate) is a plus.

Bravens 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, age, protected veterans or individuals with disabilities.

Source : Ampcus Incorporated