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Edc Project Manager Jobs in Massachusetts (NOW HIRING)

IQVIA

Senior Data Team Lead (Remote)

Boston, MA · Remote

$86K - $217K/yr

... Project Manager . * Proven success managing large global studies (1000+ patients). * Expertise with Medidata Rave, Oracle InForm, or similar EDC systems. * Strong understanding of GCP, ICH, and ...

ARTBIO

Senior Director, Clinical Operations

Cambridge, MA · On-site

$120 - $160/hr

... project management, regulatory, quality, finance, and translational and discovery research, to ... Experience with study tools, including CTMS, eTMF, Medidata RAVE, and other EDC systems. EEO ...

Care Access

Central Study Coordinator I

Boston, MA · Hybrid

The CSC also serves as a project manager for their assigned studies with their assigned PIs ... Enter data and resolve queries in EDC and other portals within appropriate time window defined by ...

IQVIA

Mgr, Database Management Systems

Boston, MA · On-site

Share new industry standards and best practices with project and study teams and departments as ... Work with Data Managers and EDC Programmers to implement new or modified global library objects (e ...

Tango Therapeutics

Site Management Leader (SML)

Boston, MA · On-site

$128K - $192K/yr

Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIs * Strong vendor management and project management skills * Leadership skills with ...

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All JobsEdc Project JobsEdc Project Manager JobsEdc Project Manager Jobs in Massachusetts

Edc Project Manager information

Does Edc Project Manager offer remote work options?

The Edc Project Manager role may offer remote work options depending on the employer's policies. Many project management positions can be performed remotely, especially with skills in collaboration tools and virtual communication. Candidates should verify specific job postings for remote work availability.

What are some common challenges faced by EDC project managers when implementing new electronic data capture systems?

EDC Project Managers often encounter challenges such as ensuring seamless integration of the new system with existing clinical trial workflows, managing diverse stakeholder expectations, and maintaining data quality throughout the study. They must also handle tight timelines and adapt quickly to regulatory changes or sponsor requirements. Effective communication with both technical teams and clinical staff is crucial to overcoming these obstacles and ensuring successful project delivery.

What are the key skills and qualifications needed to thrive as an EDC project manager, and why are they important?

To thrive as an EDC Project Manager, you need expertise in clinical data management, project coordination, and a solid understanding of Electronic Data Capture (EDC) systems, usually supported by a degree in life sciences or related fields. Familiarity with EDC platforms like Medidata Rave or Oracle InForm, along with certifications such as PMP or CDISC, is highly valuable. Strong organizational, problem-solving, and communication skills help you effectively lead cross-functional teams and manage client expectations. These competencies ensure successful EDC project delivery, regulatory compliance, and high-quality clinical trial data.

What is an EDC project manager?

EDC Project Managers are professionals who oversee the planning, execution, and monitoring of projects related to Electronic Data Capture (EDC) systems, primarily within clinical research and pharmaceutical industries. They coordinate between cross-functional teams, manage timelines, ensure regulatory compliance, and address any issues that arise during the data collection process. Their goal is to ensure that EDC systems are implemented efficiently and effectively, supporting the overall success of clinical trials. EDC Project Managers also act as the main point of contact for sponsors and stakeholders, ensuring that project objectives and quality standards are met.

What is the difference between Edc Project Manager vs Electrical Project Manager?

AspectEdc Project ManagerElectrical Project Manager
CertificationsPMP, OSHA, EDC-specific trainingPMP, OSHA, Electrical licenses
Work EnvironmentEnergy, utility, and infrastructure projectsConstruction, industrial, and commercial electrical projects
Industry UsageCommon in energy distribution and utility sectorsCommon in construction and industrial sectors
Job FocusDistribution systems, substations, and energy deliveryBuilding wiring, electrical systems, and installations

The Edc Project Manager primarily oversees energy distribution and utility infrastructure projects, focusing on energy delivery systems. In contrast, the Electrical Project Manager handles a broader range of electrical construction projects, including commercial and industrial wiring. Both roles require similar certifications but differ in industry focus and project types.

What are popular job titles related to Edc Project Manager jobs in Massachusetts? For Edc Project Manager jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Edc Project Manager jobs in Massachusetts look for? The top searched job categories for Edc Project Manager jobs in Massachusetts are:
What cities in Massachusetts are hiring for Edc Project Manager jobs? Cities in Massachusetts with the most Edc Project Manager job openings:
Edc Project Manager jobs near you

Director, IT R&D and Quality Applications

Amylyx Pharmaceuticals

Cambridge, MA

Full-time

Posted 25 days ago

Job description

The Opportunity

Amylyx is looking for a Director, IT R&D and Quality Applications to foster strong functional partnerships and provide strategic technical support.  In this role you will lead the strategy, delivery, and lifecycle management of systems supporting Research, Clinical Development, Data Management, Biometrics, Regulatory, Pharmacovigilance, and Quality functions. Additional responsibilities will include a range of activities within the information technology organization including project management, development, and maintaining procedures to ensure Amylyx has a stable, robust, and scalable set of applications to support the changing business needs and support. This role ensures the operation of scalable, compliant platforms supporting Amylyx's product development pipeline including complex clinical trials and regulatory activities.

We anticipate hiring the Director, IT R&D and Quality Applications in September 2026.

Responsibilities

  • Serve as the lead IT partner across Clinical Operations, Data Management, Biometrics.
  • Oversee systems supporting regulatory submissions, pharmacovigilance, and quality management.
  • Support complex clinical trials involving decentralized models, subject diaries, and connected devices.
  • Lead implementation and support of R&D systems including Clinical Trial management solutions including CTMS, EDC, eTMF, ePRO/eCOA, IRT, and consolidated clinical analytics solutions.
  • Spearhead use & enablement of AI solutions within R&D, Clinical & Quality systems.
  • Develop integration strategy across clinical data ecosystems including the Veeva Vault R&D Suite and analytics environments.
  • Ensure compliance with GxP regulations including ICH E6(R3), 21 CFR Part 11, and data integrity (ALCOA+).
  • Lead technology solutioning including vendor selection, RFP processes, and vendor relationship management.
  • Manage system roadmap, budgeting, and portfolio prioritization.

Required Qualifications

  • Bachelor's degree in computer science, Life Sciences, or related field.
  • 10+ years of Life sciences business applications experience with 5+ years implementing and supporting R&D / Clinical Systems.
  • Experience with clinical trial systems is required (CTMS, eTMF, eCRO, ePRO).
  • Experience with clinical data management (EDC, CDB) and Biometric analytical platforms preferred.
  • Deep expertise in Veeva Vault R&D Suite (Clinical, RIM, Quality, Safety)
  • Expertise in integrating complex clinical data sources including ePRO, wearables, and medical devices.
  • Strong knowledge of GxP regulations, CDISC standards (SDTM, ADaM) and Computer System Assurance frameworks.
  • Experience managing cross-functional teams and SaaS-based vendors
  • Excellent communication and problem-solving skills.

Work Location and Conditions

  • At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
  • Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis.
  • If outside of the New England region, you will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation.
  • When working remotely, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

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