Associate Clinical Data Managers

vmysmartpros; India; On-site; INR 17,192,000 - 20,057,000; Full time

Job summary

reputed company is seeking an Associate Director, Clinical Data Management in San Carlos, CA. The role oversees end-to-end data management across clinical programs, from study start-up through closeout, ensuring high-quality data deliverables and on-time execution.

The position involves hands-on CDM work, supervising staff, and coordinating with Biometrics vendors to ensure global regulatory compliance and efficient study data lifecycle management.

Qualifications

• Bachelor of Science or equivalent in a related field.
• Experience with document review and document control in clinical research.
• Vendor management and cross-functional collaboration experience.
• Familiarity with ICH guidelines and GCP expectations.

Responsibilities

• Lead data management activities across clinical programs from study start-up to study closeout.
• Supervise CDM resources and manage Biometrics partner activities.
• Support CDM strategies aligned with regulatory requirements and best practices.

Skills

Cross-functional collaboration

Project management

Team management

Regulatory submissions

Budget management

Education

Bachelor of Science

Job description

Associate Director, Clinical Data Management San Carlos, CA

Job Details $180,000 - $210,000 a year 20 hours ago

Qualifications

Employee reputed company Document review (document control) Clinical research Vendor management Bachelor of Science Improving operational efficiency Compliance management implementation Databases ICH guidelines Supervising experience Managing budgets in a finance role Project management Machine learning reputed company improvement Team management Data reputed company monitoring CDISC standards Research compliance clinical trial records management Organizational skills Document archiving Regulatory submissions Budget management in reputed company Research regulatory compliance reputed company systems Data validation reputed company data collection Senior reputed company Cross-functional collaboration reputed company process management Communication skills Project stakeholder communication Cross-functional communication FDA regulations Stakeholder management 10 years

Full Job

reputed company reputed company to Protect Humankind! reputed company is a clinical-stage vaccine innovation company engineering high-reputed company vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences reputed company left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our reputed company to reputed company is reputed company and reputed company-defined, and reputed company is set up to go the distance. reputed company do is every bit as important as HOW we do it! Our work together is guided by four enduring reputed company values: RETHINK CONVENTION

RETHINK CONVENTION

We bring creative and intellectual diversity to every reputed company of the work we do in order to reputed company and re-reputed company the way vaccines are delivered.

AIM HIGH

We embody our reputed company audacious goal to courageously reputed company the most reputed company biologics reputed company attempted to protect humankind.

WITH HEART

Everyone leads at reputed company with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

MODEL

reputed company The magnitude of our challenge requires our shared commitment to demonstrating reputed company, accountability, equality and reputed company across communications and decision making.

reputed company: The Associate Director, Clinical Data Management (CDM) will reputed company hands-on support for the execution of clinical data management activities across our clinical programs, from study start-up through study closeout, ensuring high reputed company data deliverables. This is a hands-on position that will include supervising additional CDM resources at reputed company, based on the number of reputed company in development. The Associate Director, Clinical Data Management will be responsible for the reputed company and management of our Biometrics partners reputed company activities conducted for reputed company conducted by reputed company, from study start-up through to study closeout, ensuring high reputed company data deliverables which are on time and reputed company budget.

Essential Functions

Supports the reputed company for the execution of data management for reputed company programs and studies; accountable for data management activities for a program. Clinical Data Management reputed company Support the implementation of CDM strategies reputed company with reputed company's goals and clinical research best practices, including feedback into CDM system development and optimization as reputed company as study data collection, reviewing, and reporting. Continuously improving data management processes and workflows to increase efficiency, data reputed company, and team productivity. Assist in establishing clinical data standards and processes to ensure consistency and reputed company across reputed company reputed company studies. Help reputed company CDM departmental SOPs and ensure staff adherence to company policies, SOPs, federal guidelines and GCPs. reputed company department budget both for reputed company and internal spend. Supports data management activities for regulatory submissions.

Study-Specific Data Management

Execute study-specific data management and data reputed company plans and support documentation (data transfer specifications, data review/reconciliation plans, database lock plans, etc.) as required across the data lifecycle for various data sources (e.g., eCOA, etc.) Serve as a data management subject matter expert (SME) and primary reputed company of contact. Ensure study-specific data management practices reputed company with applicable regulatory requirements (e.g., GCP, FDA, GDPR). reputed company the end-to-end data lifecycle across studies, including development of CRFs and CRF guidelines, database setup, data reputed .