Clinical Data Team Lead

Exciting Opportunity: Clinical Data Team Lead (WEP Clinical)

Do you want to be a part of a team that gives hope to patients living with rare and life-threatening diseases? Are you looking for career growth, challenges, or simply a more motivating role? At WEP Clinical, our business is growing and the career opportunities are endless. Our team member’s help patients every single day get early access to medicine. We challenge our team to bring thought-provoking ideas to the table. Join us and see the impact you can make

Role Objectives:
The Clinical Data Team Lead executes data management projects and leads the data management component of programs. This includes performing data management tasks and coordinating the efforts of team members and third-party contractors or consultants to deliver projects according to plans. The Clinical Data Team Lead will communicate with clients, customers, or sponsors regularly on data management program milestones and project tracking.
- Team Player
- Adaptable
- Detail Oriented
- Problem Solver

Principal Duties and Responsibilities:

- Support the collaboration with the Client on study design, eCRF design, data review and data cleaning activities
- Plan, implement, and perform data management tasks and operational aspects of individual projects
- Ensure quality of data submitted from study sites and assure timely entry in database
- Ensure the conduct of the study is in compliance with the protocol with current GCP guidelines and applicable regulatory requirements
- Identify and manage study timelines, project team milestones and project risks
- Ensure appropriate support and training are provided to designated staff per assigned project
- Help maintain positive relationships with external vendors
- Support initiatives for the development of new systems and process improvement initiatives, organizational SOPs and guidance documents
- Communicate with business development team to select and manage relationships for external vendors (such as EDC, image upload, IWR/IVR vendors)
- Work with external vendors to develop, test and implement technical tools to support business needs
- Support input into cost proposals, client presentations, or preparation of bid defenses
- Pro-actively identify potential challenges and communicate recommended solutions
- Support the DM group with vendor and customer audits as assigned

Qualifications:

- Bachelor's Degree
- 2-5 years of clinical research experience, with a minimum of 1 year of data management experience with a pharmaceutical or medical device company, hospital or CRO
- Knowledge of GCP ICH guidelines
- Data review and cleaning experience
- Computer literacy and proficient in Microsoft Office, and experience in data capture systems
- Experience with statistics, programming, and field monitoring
- Strong organizational skills and attention to detail
- Effective verbal and written communication skills

What We Offer:

- Medical, dental, and vision insurance, HSA, FSA
- Group short-term and voluntary long-term disability insurance
- Group life insurance
- 401K safe harbor plan and company match
- Paid vacation, holiday, sick, and volunteer time
- Paid maternity & paternity leave,
- Education assistance

✨ 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 a decade of experience distributing products worldwide to treat unmet patient needs.

We're Committed to Our Team:
WEP has many initiatives in place 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)

Open Label Extension Studies (OLE)

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 quali