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Clinical Data Manager

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.



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, HSA

Voluntary short-term and long-term disability insurance

Voluntary life insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid 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.


#LI-Remote

Average salary estimate

$80000 / YEARLY (est.)
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$70000K
$90000K

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What You Should Know About Clinical Data Manager, WEP Clinical

Are you ready to take the next step in your career? Join our amazing team at WEP Clinical as a Clinical Data Manager! Here, you'll be at the forefront of clinical research, ensuring that our data management activities lead the way in quality and compliance. Your innovative mindset will help us tackle the challenges that come with multiple clinical trials, where you'll oversee everything from the design and validation of clinical databases to communicating with our valued sponsors. You won't just be crunching numbers; you'll be making an impact on clients and patients alike by enhancing data quality and adhering to regulatory guidelines. Plus, you'll collaborate with a diverse team to ensure seamless operations and major milestones in our studies. If you're a detail-oriented, adaptable, and strong communicator, WEP Clinical is the perfect place for you to grow your career while also contributing to our mission of advancing health solutions worldwide. Working with top-notch professionals in a supportive and engaging environment, you will have the chance to develop systems and contribute to process improvements that truly matter. Join us, and be a part of a dynamic organization dedicated to embracing diversity, equity, and inclusion in all aspects of our work!

Frequently Asked Questions (FAQs) for Clinical Data Manager Role at WEP Clinical
What are the key responsibilities of a Clinical Data Manager at WEP Clinical?

As a Clinical Data Manager at WEP Clinical, you’ll lead the data management activities for multiple clinical trials. This includes developing, testing, and validating clinical databases, ensuring regulatory compliance, and maintaining high-quality data throughout the study lifecycle.

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What qualifications do I need to apply for the Clinical Data Manager position at WEP Clinical?

To apply for the Clinical Data Manager position at WEP Clinical, you need a Bachelor’s Degree in a related field, knowledge of GCP and ICH guidelines, experience in clinical research, and strong communication skills. Familiarity with data capture systems and experience in data review are also beneficial.

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How does WEP Clinical support the professional development of its Clinical Data Managers?

WEP Clinical is dedicated to the growth and development of its employees. As a Clinical Data Manager, you will have access to various initiatives that encourage wellness and professional development, including training programs and opportunities for advancement within the organization.

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What type of projects will a Clinical Data Manager at WEP Clinical work on?

A Clinical Data Manager at WEP Clinical will work on a variety of impactful projects related to clinical trials, including Expanded Access Programs and Named Patient Programs, helping to ensure that patients and physicians benefit from early access to new treatments.

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What is the work environment like for a Clinical Data Manager at WEP Clinical?

At WEP Clinical, the work environment is collaborative and inclusive, promoting teamwork and innovative thinking. Employees are encouraged to bring ideas to the table, and the company fosters a positive atmosphere that focuses on both personal and professional growth.

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Common Interview Questions for Clinical Data Manager
Can you describe your experience with clinical database management?

When answering this question, highlight specific experiences you've had in designing, developing, and managing clinical databases, emphasizing your knowledge of GCP and ICH guidelines.

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How do you ensure data accuracy and quality throughout a clinical trial?

Discuss the strategies you utilize for data validation, including regular audits and checks, as well as your methods for collaborating with study sites to maintain data integrity.

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What steps do you take to prepare for an audit or inspection?

Explain your structured approach to documentation and compliance, including regular reviews and inspections of all data management processes leading up to the audit to ensure readiness.

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How do you manage relationships with external vendors?

Describe your communication strategies and how you ensure that vendor services align with project needs and timelines while maintaining quality.

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What is your approach to process improvement in data management?

Share specific examples of initiatives you’ve proposed or implemented to enhance data management processes, including developing SOPs and training materials.

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How do you handle deviations from study timelines?

Discuss your problem-solving skills and proactive communication approach to manage risks effectively, including how you would notify stakeholders and adjust timelines.

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What tools or software are you proficient with for data capture?

Mention specific software and tools you have used for data capture and management, highlighting any relevant certifications or special training you have.

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Describe your experience working with clinical teams.

Emphasize your collaboration skills and provide examples of how you’ve successfully worked with cross-functional teams to achieve study objectives.

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How do you stay informed about changes in regulatory guidelines?

Share your methods for keeping up-to-date with industry standards, such as attending webinars, participating in professional organizations, or following reputable publications.

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What do you see as the biggest challenge in data management in clinical trials today?

Reflect on current trends and challenges, discussing how you would address these issues based on your knowledge and experiences in the field.

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WEP Clinical is a pharmaceutical services company focused on providing patients and health institutions access to much-needed drugs through Expanded Access Programs (EAP) and Named Patient Programs (NPP). WEP Clinical was founded in 2008 and is he...

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Full-time, remote
DATE POSTED
December 8, 2024

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