Implementation Lead, CTMS
50 Northern Avenue Boston, Massachusetts 02210
Position Title: Project Manager, Clinical Operations
Job Location: Boston
Interview Expectations: onsite
Local Candidate: preferred
Required Skill Sets: CTMS, ClinOps, Pharma
This organization is currently looking to expand its Clinical Development Systems team within the IT department to support a growing number of exciting new projects. The department is responsible for accelerating the drug development process through technology. The goal is to enable innovation in Clinical Development while efficiently getting medicine to patients.
You will be working closely with a team of passionate and dedicated leaders within Development. When you join our IT department, you will see that our culture is fast-paced, collaborative and we are “ fearless” in striving to do what has never been done before. Employees can expect to be challenged, gain exposure to cutting-edge technologies, and feel valued by the community. Be fearless, be innovative, be passionate…. join us and help build something different and redefine what IT can be for us and our patients!
The Project Manager will be a leader within GIS (Global Information Services). You will ensure delivery of solutions in support of GIS’ business customers in Global Medicine Development and Affairs, which relies on a cadre of commercial-off-the-shelf (COTS) and internally developed systems. You will work with leadership in the business organization to develop strategies for supporting their evolving needs. Additionally, you will ensure team members maintain reliable, scalable and compliant systems that meet business needs, As well as leading running the design and delivery of improvements that provide creative solutions and integrations.
- Work with partners and lead requirements gathering and analysis for the Clinical Operations Systems. You are comfortable using both waterfall and agile techniques. You will architect technical and innovative solutions using existing technology or newly acquired platforms.
- Serve as the Technical authority on projects of all sizes and types. From minor system changes on custom systems and commercial products, to major initiatives involving new systems implementations with complex data integrations.
- Lead and drive project teams (internal and external) in solutions delivery: from solution definition to final delivery and acceptance. Your fiduciary responsibility will keep the projects within budget.
- You will be responsible for status reporting to GIS Management, Business counterpart, and delivering solutions to client expectations.
- Lead the transition of newly delivered solutions into long term production operations via managed services. Work with managed service providers to take over day-to-day maintenance and support activities. Ensure optimal on-going service performance of the solution through oversight and direction of managed services staff.
- You will also be in charge to decommission existing systems deemed to be replaced by new platform and ensure data integrity.
The Project Manager will excel at the following:
- Business knowledge: Understand the Clinical Operations processes from the sponsor and clinical site’ s perspective, and regulatory environment under which they operate now and into the future.
- Relationship management: Be responsible for the relationship with Clinical Operations business partners, and lead the conversation to identify their needs, not necessarily their wants. Propose and lead efforts to deliver an innovative a Study Management System and Investigator to creative solutions to move to their future state, while delivering consistent communication to GIS and business management on progress.
- Technical literacy: as a technologist you “ know your craft”, based both on professional, hands-on experience, and you are acquiring knowledge and experience in technology constantly. You have had experience of hands-on coding experience and have a good understanding of modern design patterns and current technologies (cloud, noSQL, API, security…)
- Ability to Deliver: You are a roll up the sleeve leader who will operate within a lean team in a fast pace environment. As such you will be responsible for the delivery of Clinical Operation systems (Study Management System/Investigator platform) and associated interfaced. You will show your ability to manage external vendor and ensure timelines are met according to specifications.
- At least 7 years of work experience that demonstrates the ability to design and deliver IT business solutions, demonstrating a broad understanding of available applications and technical architectures.
- Substantial experience in the pharmaceutical or biotech industries, with an end-to-end understanding of the drug development process and the systems used to support it.
- Demonstrated ability to organize, lead, and drive a multi-functional team to results. At least 5 years of experience performing project management activities, including:
- Formulating project plans for complex projects with multiple work streams.
- Leading project personnel, financials, and schedule.
- Tracking, monitoring, and reporting on project performance.
- Effectively and actively handling client expectations.
- Ability to communicate and partner with business customers. At least 5 years of experience in a position requiring frequent interaction with senior business leaders and their staff, building partnerships with them to understand their business needs and define application requirements.
- BS in Computer Science or Information Systems, and 5+ years of relevant work experience.
- Prior experience as a hands-on software developer using a major language (e.g. Java, C, C++, Python, etc.)
- Solid understanding of modern IT concepts such as SaaS, cloud computing, virtualization and information security.
- Proven ability to work independently and proactively advance and inform management of risks and issues before they become a crisis.
- Experience following a defined Software Development Life Cycle (SDLC) and employing development operations (dev ops) fundamentals such as source code control, and controlled deployment of builds across development, test, and production environments.
- Knowledge of, and experience with, agile/lean methodologies.
- Excellent written and oral interpersonal skills. Ability to effectively communicate highly technical information to different types of audiences, including senior business leaders, IT leadership, and junior staff