Clinical Data Manager

ICONMA; Thousand Oaks (CA); Remote; USD 90,000 - 130,000; Full time

Job summary

A biopharmaceutical company is seeking a Clinical Data Manager for a remote role. The successful candidate will oversee data management tasks, ensuring quality and consistency across projects, while managing vendor relationships and compliance with regulatory guidelines. Applicants should possess strong leadership and communication skills, along with extensive clinical research experience.

Benefits

Health Benefits

Referral Program

Excellent growth and advancement opportunities

Qualifications

• Experience in Clinical Data Management and Oversight in the Biopharmaceutical industry required.
• Strong understanding of GCP, FDA regulations, and clinical trial processes.
• Excellent interpersonal and organizational skills.

Responsibilities

• Coordinate daily oversight of data management tasks and ensure project timelines.
• Review all study-related documents for consistency and quality control.
• Lead electronic submission activities and manage vendor relationships.

Skills

Leadership

Communication

Problem Solving

Project Management

Flexibility

Decision Making

Team Collaboration

Education

Doctorate Degree

Master's Degree

Bachelor's Degree

Associate's Degree

High School Diploma/GED

Job description

Our Client, a Biopharmaceutical company, is looking for a Clinical Data Manager for their Remote location.

Responsibilities:

• Project level coordination and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines.
• Ensure that quality control checks are occurring such that quality databases are delivered and batch cleaning SLAs are conducted as per contract.
• Review and approve study specific training and lead vendor results and relationship at the study level.
• Communication of project level issues including processes, timelines, resourcing, performance, etc.
• Review of all study level non-DM documents for awareness and project level consistency.
• Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level.
• Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.

Requirements:

• Doctorate Degree
• Or
• Master's Degree and 2 years of clinical experience
• Or
• Bachelor's Degree and 4 years of clinical experience
• Or
• Associate's degree and 8 years of clinical experience
• Or
• High school diploma/GED and 10 years of clinical experience
• Degree in life science, computer science, business administration or related field.
• Clinical Data, Project and Planning Management experience in the Pharmaceutical or Biotech industry.
• Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc).
• Knowledge of relevant therapeutic or product area
• Clinical research experience obtained working on industry-sponsored global clinical trials
• Excellent oral and written communication skills
• Proven ability to lead, manage, and motivate others in a complex, multi-functional environment
• Experience working in a global, matrix organization on global clinical development programs
• Knowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert advice
• Broad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines
• Solid understanding of Biopharmaceutical/Healthcare Compliance
• Proven ability to anticipate and resolve problems
• Excellent interpersonal and organizational skills
• Professional collaboration and leadership skills
• Experience anticipating and resolving problems
• Experience writing and presenting clearly on scientific and clinical issues
• Experience collaborating and leading cross-functional teams
• Team leadership
• Strong written and oral communication
• Flexibility
• Initiative
• Problem solving
• Project management
• People management
• Decision making
• Scientific/technical excellence

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.