Senior 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 Senior Clinical Data Manager leads and oversees the data management activities across multiple programs, including Clinical Trials, EAP, PA-NPP, and OLE, ensuring high-quality data and compliance with regulatory requirements. This role is responsible for managing the design, development, and validation of clinical databases, maintaining robust relationships with external vendors, and actively communicating with Sponsors. In addition, the Senior Clinical Data Manager oversees data integrity, prepares the team for audits and inspections, and ensures continuous compliance. This role also involves direct engagement with customers to align data management strategies with client needs and expectations, reinforcing the company’s commitment to excellence in clinical data management.

The Ideal Candidate:

• Team Player
• Adaptable
• Detail Oriented
• Strong Communicator

What You'll Do:

• Oversee data management activities across clinical trials, ensuring compliance with regulatory requirements and high-quality data output.
• Plan, develop, test, and validate clinical databases and EDC systems to meet trial needs.
• Maintain communication with clients and sponsors on project milestones and progress.
• Collaborate with clients and cross-functional teams on study design, eCRF design, data review, and data cleaning.
• Monitor data quality from study sites, ensuring timely and accurate database entries and leading data cleaning tasks.
• Coordinate with external vendors to ensure quality services are delivered on time.
• Support internal teams by providing guidance and demonstrating data management platforms and processes.
• Track and manage study timelines, proactively addressing project risks and deviations.
• Ensure the accuracy and completeness of clinical trial data through validation and review.
• Prepare documentation for regulatory submissions, audits, and compliance with GCP, ICH, and regulatory requirements.

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 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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