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Edc Project Manager Jobs in California (NOW HIRING)

Ardelyx

Clinical Trial Manager

Newark, CA · On-site +1

Participate in and support user acceptance testing (UAT) for clinical systems, (e.g., EDC IRT ... Strong project management skills, including managing of timelines, budgets, and cross-functional ...

Ardelyx

Clinical Trial Manager

Newark, CA · On-site +1

$136K - $160K/yr

Participate in and support user acceptance testing (UAT) for clinical systems, (e.g., EDC IRT ... Strong project management skills, including managing of timelines, budgets, and cross-functional ...

Shifamed

Sr. Clinical Trial Manager

Los Gatos, CA · On-site

Project Management & Reporting * Build and maintain integrated project plans that define scope ... Select and manage CROs, core labs, EDC and eTMF providers, independent monitors, and other vendors ...

Shifamed

Sr. Clinical Trial Manager

Los Gatos, CA · On-site

$140K - $180K/yr

Project Management amp; Reporting * Build and maintain integrated project plans that define scope ... Select and manage CROs, core labs, EDC and eTMF providers, independent monitors, and other vendors ...

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All JobsEdc Project JobsEdc Project Manager JobsEdc Project Manager Jobs in California

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

Associate Director, Clinical Data Management

Revolution Medicines

Redwood City, CA • Hybrid

Other

This job post has expired today. Applications are no longer accepted.

Job description

The Opportunity:

This position has a key role in the day-to-day management of Clinical Data Management (CDM) activities. Including timely and professional management of clinical trial data for all relevant phases. Represents Revolution Medicines (RevMed) CDM in Clinical Team meetings. The Associate Director, Clinical Data Management, will be required to collaborate closely with other functional leaders to ensure clinical trial success. Defines project-level data management strategy. Identifies requirements for capturing and processing of clinical data ensuring accuracy, consistency, and completeness. Manage external vendors providing clinical data. Manages and/or perform data management tasks according to strict quality standards including SAE reconciliation, third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution. Provides CDM oversight of outsourced and partner-resourced clinical trials including scoping trials, project management, relationship management, approval of deliverables, and coordination of internal reviewers.

  • Plans, coordinates, and manages CDM tasks for clinical studies.

  • Participate and review CRO proposals.

  • Acts as primary liaison with CROs, third party data vendors, EDC vendors.

  • Reviews clinical protocols and cross functional plans.

  • Serves as primary reviewer or author of case report forms (CRFs) and CRF completion guidelines.

  • Overseas and participates in all aspects of EDC database development, testing, maintenance, and lock/unlock.

  • Ensures Data Management Plans are followed through the course of the studies.

  • Sets and manages Data Management project timelines.

  • Provides comprehensive status updates to project team members.

  • Address data issues identified by cross-functional team members, accountable for external data vendor documentation, management, and reconciliation.

  • Assist in defining and creating data listings, summary table validation, data specifications, and process data transfers in preparation for statistical review and data management audit.

  • Implements data standardization and maintains data model across projects.

  • Direct management and mentoring responsibilities for internal data management team members.

  • Lead department initiatives e.g., development of SOPs.

  • Other duties as assigned.

Required Skills, Experience and Education: 

  • MS, BS/BA degree, or other suitable qualification with relevance to the field.

  • 11 or more years' direct experience of designing and running early-stage or late-stage clinical trials.

  • Knowledge of, and experience with, clinical databases, standards, medical terminology, medical coding dictionaries, quality control processes, and auditing procedures.

  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines.

  • A demonstrable record of strong leadership and teamwork.

  • Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.

  • Excellent written and verbal communication skills.

  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.

  • Experience from industry is essential.

Preferred Skills:

  • Oncology experience, especially in solid tumors.

  • 5 or more years' direct line management experience. 

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