Digital Project Manager / Senior DPM, Clinical Data Management

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us. We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization. Experience and contribute to our unique culture while you develop and expand your career!

DIGITAL PROJECT MANAGER / SENIOR DPM, CDM

Summary

The Digital Project Manager or Senior Digital Project Manager in CDM is responsible for developing, communicating, and overseeing detailed CDM digital timelines to ensure data and application deliverables are provided on time. These timelines are specific to the implementation of digital solutions in clinical trials, including eCOA, mHealth, eConsent and other digital solutions with a primary focus on eCOA. The Project Manager, CDM organizes and leads cross-functional team meetings to ensure accurate accountability and reporting. This role reports into the Director eCOA.

Responsibilities

• Provide project management expertise and collaborate with the Project Team Leader and Lead Data Manager to lead the CDM timelines for startup, conduct, and closeout.
• Oversee and manage digital vendors delivering solutions for the trial including schedule, costs, quality and delivery.
• Facilitate, and lead internal and external processes such as, requirements sign off and version control, translations, IRB material submissions, change management and user acceptance testing.
• Follow and contribute to a process of digital delivery from final protocol to data delivery.
• Ensure integration of applicable cross-functional study tasks, as they relate to the CDM digital deliverables, are incorporated to increase visibility and accountability.
• Facilitate team meetings, cross-functional communication, and decision-making; ensure alignment with internal and external stakeholders, project sub-teams and functional area partners.
• In collaboration with the Project Team Leader and Lead Data Manager, prepare project planning documents (e.g., readable timelines for the project team, roll-up dashboard reports, etc.) for management review.
• Communicate, document, and archive team actions and decisions; act as a primary contact for project team-related information around CDM timelines.
• Identify critical project risk factors and mitigating actions.
• Identify opportunities for process improvements in project team activities; partner with the team leader to ensure the team achieves and maintains a high-level of sustainable performance, by contributing to appropriate team management best practices.
• Partner with Global Project & Portfolio Management to develop a CDM environment within the larger Project Web Application (PWA) environment to ensure maximum visibility to study updates with minimal human involvement (e.g., appropriate linking across PWA as needed)
  
  

Requirements

• BA or BS degree in life sciences, engineering, or business administration; advanced degree desired.
• PMP Certification and/or Project Management training desired.
• Minimum of 3 years of experience in the pharmaceutical or biotechnology industry with at least five years of relevant experience in the delivery of eCOA and digital solutions application delivery and project management, including significant experience in a cross-functional team environment.
• Solid understanding of digital product development activities in clinical trials, including key interdependencies, and knowledge of proven development strategies and tactics.
• Expert analytical skills for integrating and interpreting interdisciplinary project information; thorough understanding of the drug/vaccine development process.
• Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management.
• Strong team management skills, including facilitation, conflict resolution, and team development.
• Proven influence management and communication skills, at all levels of the organization.
• Working knowledge of MS Word, Excel, PowerPoint, Visio, and Project, including PWA.
• Excellent written and oral communication skills.
  
  

Please visit our website, www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003288

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=to%20Applicants%C2%A0%C2%BB-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $87,588 to $124,100

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.