WEP Clinical
Clinical Data Manager
Job Description
Role Objectives: The WEP Clinical Data Manager leads and oversees the data management activities for multiple clinical trials, ensuring high-quality data and compliance with regulatory requirements. This role involves the management of the design, development, and validation of clinical databases, maintaining robust relationships with external vendors, and actively communicating with Sponsors. As a Clinical Data Manager, you will ensure that all data management processes adhere to regulatory guidelines and prepare the team for audits and inspections, while also engaging directly with customers to align data management strategies with client needs and expectations.
The Ideal Candidate:
- Team Player
- Adaptable
- Detail Oriented
- Strong Communicator
What You’ll Do:
- Lead comprehensive data management activities for multiple clinical trials, ensuring regulatory compliance and data quality.
- Plan, develop, test, and validate clinical databases and EDC systems to meet trial needs.
- Collaborate with clients and cross-functional teams on study design, eCRF design, and data cleaning.
- Monitor and ensure data quality, accuracy, and timely database entries from study sites.
- Manage external vendors to deliver quality services within project timelines.
- Maintain regular communication with clients to update on milestones and progress.
- Ensure adherence to GCP, ICH, and regulatory requirements, supporting audits and inspections.
- Proactively track study timelines, managing risks and deviations effectively.
- Contribute to process improvement by developing systems, SOPs, and guidance documents.
- Support business development activities, including preparing presentations and bid defense materials.
What You’ll Need:
- Bachelor’s Degree in a related field
- Knowledge of GCP and ICH guidelines.
- Experience in data review and cleaning activities
- Proficiency in MS Office suite and data capture systems.
- Experience in clinical research, preferably with pharmaceutical or medical device companies, hospitals or CROs.
- Familiarity with statistics, programming, and field monitoring
- Effective communication skills and leadership skills
What We Offer:Medical, dental, and vision insurance, FSA, HSAVoluntary short-term and long-term disability insuranceVoluntary life insurance401K safe harbor plan and company matchPaid vacation, holiday, and sick timePaid maternity & paternity leave
What sets us apart:WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We’re Committed to Our Team:WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We’re Committed to DEI:At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone’s unique identities.
Our services include:Expanded Access Programs (EAPs)Named Patient Programs (NPPs)Clinical Trial Supplies (Comparator & Ancillaries)Wren Nursing (Clinical Trial Home Nursing & Clinical Education)Hospital Supply of Unlicensed Medicines
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
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