Senior Clinical Data Manager

Worldwide Clinical Trials · North Carolina, United States · 1 wk ago

RemoteRemoteAnalyst$157k/yrFull-time

About the role

We are a global, midsize CRO that pushes boundaries, innovates, and invents. Our mission is to work with passion and purpose every day to improve lives.

Responsibilities

Oversee, lead, manage, and provide technical expertise within assigned projects to ensure they are executed in an efficient, accurate, and timely manner to the Sponsor’s satisfaction.
Provide fully independent and autonomous leadership of data management services (start-up, conduct, and closeout) across multiple complex global projects/programs.
Ensure appropriate resources are allocated to complete all data management (DM) activities on time and within budget.
Prepare DM trial documentation, including Data Management Plans (DMPs), Database Specifications, Edit Check Specifications, CRF Completion Guidelines (CCGs), and Data Transfer Agreements (DTAs).
Ensure effective User Acceptance Testing (UAT) is performed.
Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, Interactive Response Technology (IRT), Central Laboratory).
Oversee data cleaning activities.
Produce metrics to monitor progress of trial activities.
Avoid all database lock activities on time.
Represent Worldwide Clinical Trials Data Management at both internal and external study meeting calls, including providing input.
Monitor project scope, budgets, and risks and alert DM Management of any concerns.
Liaise with DM Management at regular intervals to discuss progress and any outstanding issues (e.g., during Project Review Meetings).
Collaborate with internal Worldwide Clinical Trials departments working on the same project.
Provide feedback on process improvements to DM Management and/or Subject Matter Experts (SMEs).
Participate, as necessary, in sponsor audits, regulatory authority inspections, and other third-party meetings.
Perform other duties as assigned.

Requirements

Excellent attention to detail
Excellent written and verbal communication skills
Strong knowledge of data management best practices and technologies as applied to clinical trials
Strong communication and interpersonal skills to collaborate with cross-functional internal and external teams
Strong understanding of clinical trial processes, protocol documents (protocols, Statistical Analysis Plans (SAPs), Case Report Forms (CRFs), study reports), and related procedures
Strong analytical and problem-solving skills
Independent and autonomous project oversight skills

Qualifications

Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related discipline, or equivalent relevant experience
Minimum of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries

Skills

Benefits

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $79,000.00 - $157,000.00 The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity.

Pay

The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $79,000.00 - $157,000.00

Schedule

N/A