Sr. Clinical Data Manager (Remote) (Contract)

Planet Pharma; California (MO); Hybrid; USD 65,000 - 107,000; Full time

Job summary

Planet Pharma is seeking a senior data manager with extensive data management experience to lead data operations across internal project teams and CRO partners. The role requires setting data standards, supervising staff, and ensuring compliant, timely delivery of study datasets.

You will review study startup documents, DMPs, coding, eCRF design, validation, and UAT; coordinate cross-functional data reviews; monitor timelines; and mentor junior data managers, all while maintaining rigorous

Qualifications

• At least 9 years of data management experience, or 6 years with a BS, or 4 years with an MS.
• Minimum 4 years in pharmaceutical/biotech or CRO environments.
• Strong knowledge of FDA/EMA/ICH/GCP guidelines and data handling in clinical trials.

Responsibilities

• Oversee all phases of data management for internal projects and CROs.
• Review study startup documents, DMP, QC, coding, validation, and eCRF specs.
• Supervise data cleaning, DCF and query tracking, and reconciliation.
• Lead database build, validation, and user acceptance testing of clinical databases.
• Coordinate cross-functional study team, client, and CRO meetings.
• Monitor data quality metrics and project timelines.
• Mentor Clinical Data Managers I and II.

Skills

Data management

SQL

SAS

Clinical data standards

Communication skills

Multidisciplinary teamwork

Education

BS in science or technical discipline

MS in science or technical discipline

Tools

eCRF systems

Query tracking tools

Job description

JOB DESCRIPTION / SUMMARY

The qualified candidate will have at least 9 years of Data Management experience, or B.S./B.A. in a science or technical discipline degree with 6 years of Data Management experience, or MS degree with 4 years of Data Management experience.

4 years in the Pharmaceutical/Biotechnology industry or CRO environment highly desired.

RESPONSIBILITIES

The main responsibilities of this role include but are not limited to the following:

• Manage all phases of data management activities and support to internal project teams, clients, and Clinical Research Organization (CRO) including the following:
• Review and approve study startup documents, Data Management Plan (DMP), Reconciliation Plan, Quality Control Plan, Coding Plan, Validation Plan, Communication Plan, and other documentation as required.
• Supervise data cleaning activities including processing Data Clarification Form (DCF)/query tracking and conducting and orchestrate scheduled cross-functional data review/reconciliation, identification of issues, and track through resolution Design and/or approve final Electronic Case Report Form (eCRF)/Case Report Form (CRF), edit check specifications, case report form guidelines, and electronic data handling conventions
• Manage database build activities, database validation, and review and execution of User Acceptance Testing of clinical databases
• Facilitate internal study team, client, and CRO meetings
• Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to manager any requested out of scope activities
• Assist manager in monitoring timelines and managing resources to meet timelines
• Identify inconsistencies and inefficiencies in data management processes and recommend solutions
• Direct team members in daily activities including training and supervising Clinical Data Managers I and II

KNOWLEDGE & SKILL REQUIREMENTS

• 9 years data management experience, or B.S. /B.A. in a science or technical discipline degree with 6 years data management experience, or MS degree with 4 years data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment
• Meet the requirements of a Clinical Data Manager II with a high degree of proficiency and autonomy
• 3 years’ experience supervising Clinical Data Managers and team activities
• Ability to program in SQL or SAS desirable, but not required
• Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes
• Excellent oral and written communication skills
• Ability to work in a collaborative and multi-disciplinary environment
• Attention to detail, ability to prioritize and manage multiple projects with competing and aggressive timelines
• Good knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonization (ICH) guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing

Pay $70-78/hr based on experience level