- Lead clinical data management oversight of outsourced clinical trials for Sagimet clinical trials including project management, vendor management, coordination of internal reviews, and approval of day-to-day data management deliverables.
- Set up data management vendors as required, including review of RFPs, reviewing, and negotiating data management budgets and contracts.
- Oversight of all DM plans and activities e.g. ECRF's CCG's edit checks etc.
- Liaising with study management CRO to ensure site training and timely initiation.
- Provide direction and guidance to team members, including consultants and vendors, as well as other functional groups in Data Management area, to achieve study goals and milestones.
- Oversee database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standard and regulatory authority requirements.
- Responsible for sponsor user acceptance testing, including documenting findings and resolving with CRO
- Oversee data management activities including reviewing data management documents, data flow metrics, and driving data snapshot/closeout activities.
- Proactively identifies risks and execute risk mitigation strategies; Maintains timely communication with both upper management and cross-functional teams.
- Oversees CRO/Vendor activities to ensure GCP compliance, quality expectations are met, and timelines are adhered to.
- Contribute to program deliverable timeline creation and project re-forecasting.
- Support data management activities for regulatory submissions
- Performs additional duties as assigned.
- BS degree required (in life science or related field preferred) with minimum of 4 years of hands-on data management/CDM experience in CRO, biotech or pharmaceutical industry
- Experience leading clinical studies from study start up to database lock and managing multiple programs, and/or multiple studies within a program
- Strong vendor oversight experience
- Experience managing and collaborating with multiple external data providers such as ePRO, central lab, specialty lab and central readers
- Experience working with eTMF systems and inspection readiness activities
- Understanding the principles of clinical research, ICH GCP (Good Clinical Practice), 21 CFR part 11, GCDMP (Good Clinical Data Management Practices) and related regulatory requirements
- Expertise with CDISC standards, including CDASH and SDTM; Working knowledge of SAS or SQL preferred
- Proficiency with Medidata Rave EDC, Clinical Data Repositories and Visualization software
- Proficient in Microsoft Word, PowerPoint, MS Project, Outlook and Sharepoint
- Ability to use a combination of Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require
- Experience in MASH/NASH trials preferred
- Regulatory submission, audit experience preferred
- Ability to work well in a team environment both as a leader and a contributor
- Excellent communication skills (written and oral) across all organizational levels
- Collaborative, respectful, agile and transparent work style
-
Data Privacy Manager
13 hours ago
PrismIT Corp San Jose, United States**Position: Data Privacy Manager for Global Marketing Operations.** · **Location :San Jose CA /( Remote)** · **Contract To Hire** · - **Primary first POC for Privacy Queues (Marketing and PCOE), Events and Marketing Assessments**: · - **Manages the centralized Marketing Privacy S ...
-
Data Science Manager, Growth
13 hours ago
Instagram San Francisco, United States**Data Science Manager, Instagram Growth Responsibilities**: · - Drive analytics projects end-to-end in partnership with teams from Engineering, Product Management and across the Analytics community to inform, influence, support, and execute product strategy and investment decisi ...
-
Privacy and Data Policy Manager
1 week ago
Meta San Francisco, United States**Privacy and Data Policy Manager Responsibilities**: · - Track, and analyze, policy and legislative trends related to privacy and data use, with a particular emphasis on artificial intelligence, and share insights with internal partners to help guide development of products and ...
-
Director, Vm Data Management
4 days ago
PG&E Corporation Oakland, United StatesRequisition ID # 156964 · **Job Category**: Information Technology · **Job Level**: Director/Chief · **Business Unit**: Operations - Other · **Work Type**: Hybrid · **Job Location**: Oakland · Position Summary · The mission of the Vegetation Management (VM) Data Management Progra ...
-
Manager, Data Collection Fleet, Autonomy
2 days ago
Rivian Palo Alto, United StatesAbout Rivian: · Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. · As a company, we constantly challenge what's possible, never simply accepti ...
-
Principal Product Manager, Data Platforms
1 week ago
Activision San Francisco, United States**Job Title**: Principal Product Manager, Data Platforms - Activision Blizzard Media · **Reporting to**: Senior Director, Product Management · **Location**:San Francisco, CA · **Your Role Within the Kingdom**: · Want to empower the world's best games? Interested in defining the f ...
-
Data Center Site Acquisition Manager
1 week ago
ByteDance San Jose, United StatesFounded in 2012, ByteDance's mission is to inspire creativity and enrich life. With a suite of more than a dozen products, including TikTok, Helo, and Resso, as well as platforms specific to the China market, including Toutiao, Douyin, and Xigua, ByteDance has made it easier and ...
-
Senior Manager, Business Data Operations
5 days ago
BeiGene San Mateo, United States**General Description:** · The Senior Manager Business Data Operations will partner with Global business teams across BeiGene for building & maintaining a modern and scalable data platform. This position will report to the Associate Director, Commercial Data Management and will p ...
-
Technical Product Manager, Data
1 week ago
Accumulus Synergy Burlingame, United StatesJob Description · Accumulus is seeking a Technical Product Manager with data modeling experience. · Starting day one, you will have the unique opportunity to support the growth of Accumulus through playing a key role in the development and enhancement of our platform, collaborat ...
-
Product Lead
1 week ago
Stellic San Mateo, United States**About Stellic** · Stellic is a unified SaaS platform designed to empower all students on their way to degree completion and career success. Originally built by students to more effectively plan ahead, today we're really proud to serve all segments of higher ed, at institutions ...
-
Quality Assurance Specialist
4 days ago
Actalent San Mateo, United States Full timeDescription: · 20% BRR · 80% Analytical focused · • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements · • Serves as QA Lead for clinical and commercial projects. · • Leads quality investigations/deviations/ ...
-
Document Control And Training Specialist
1 week ago
Actalent San Mateo, United States Full timeSeeking 1 Document Control and Training Specialist · HYBRID role, onsite in Foster City, CA · Description: · • Authors administrative changes to department documents. · • Facilitates end to end management of the documents, including training requirements impact assessment, review ...
-
Document Control And Training Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · • Authors administrative changes to department documents. · • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedure ...
-
Document Control And Training Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · • Authors administrative changes to department documents. · • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedure ...
-
Document Control And Training Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · • Authors administrative changes to department documents. · • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedure ...
-
Document Control And Training Specialist
1 hour ago
Actalent San Mateo, United States Full timeDescription: · • Authors administrative changes to department documents. · • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedure ...
-
Document Control And Training Specialist
4 days ago
Actalent San Mateo, United States Full timeDescription: · • Authors administrative changes to department documents. · • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedure ...
-
Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeQuality Assurance Specialist · HYBRID role, onsite in Foster City, CA · Description: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilanc ...
-
Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for Gilead products from the US and Canadian markets.Documents in Gilead Quality System for investigation for product complaints and triages safety events to Gilead Pharmacovigilance Department. Performs or provides support for product ...
-
Quality Assurance Specialist
1 day ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. Performs or provides support for product complaint investi ...
Data (Clinical) Manager - San Mateo, United States - Sagimet Biosciences
Description
About Us
Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet's lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of NASH, for which there are no treatments currently approved in the United States or Europe. FASCINATE-2, a Phase 2b clinical trial of denifanstat in NASH with liver biopsy-based primary endpoints, was successfully completed with positive results. For additional information about Sagimet, please visit
Job Description
The Clinical Data Manager will be responsible for daily data management tasks for all phases of clinical trials including CRO/vendor oversight and support other functional areas such as clinical operations, statistical programming, and biostatistics. The Data Manager will ensure the accuracy, consistency, completeness, and high quality of the clinical database. The role will be to work closely with cross-functional teams on the clinical development program, health authority submissions, presentations, and publications across internal and external stakeholders.
Key Data Manager Responsibilities
Qualifications:
Compensation
The expected base salary range for this role is $130,000 - $165,000 Compensation will be based on a variety of factors, including experience, qualifications, and internal equity. Sagimet offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Sagimet through this page. We require that all Recruitment Vendors (e.g., search firms, recruitment agencies and staffing companies) have a fully executed, formal written agreement on file with Sagimet prior to submitting candidates. Any resumes submitted through the website or directly by Recruitment Vendors will be considered unsolicited. Unsolicited vendor submissions do not constitute any actual or implied contract with Sagimet and Sagimet will not be responsible for any purported fees.
Data (Clinical) Manager professionals in San Mateo
-
Santanu Biswas
Adobe Campaign Specialist | AEP | RT CDP | AJO