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Clinical Trial Registries With And EudraCT

Alpha Consulting Corp.

This is a Contract position in Madison, NJ posted December 24, 2019.

CLINICAL TRIAL REGISTRIES WITH CLINICALTRIAL.GOV AND EUDRACT MADISON, NJ Project Description: The Clinical Trial Registries Associate is a member of the Global Clinical Trial Registries Team within Business Operations, part of Drug Development Operations.

The Clinical Trial Data Registries Associate’s key responsibilities include the following: Provide support in quality oversight of the Registry health for studies within and across programs.

Contribute to Registry submission activities.

Provide guidance in global Registry requirements.

Provide support for Registry submission process improvement activities.

This position is office-based and may require travel both within and across regions.

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all the Client’s policies and procedures.

Key Duties / Responsibilities: Study Support: Provide oversight on standard processes for registries and submission timelines to assigned study teams.

Establish and Maintain Global Clinical Trial Registries: Collaborate with study teams to complete Initial Registrations, Standard Maintenance updates, and Results Submissions for applicable registries (i.e. and EudraCT) Compile and maintain registry submission related documentation in internal systems on a timely basis.

Subject Matter Expert for Global Clinical Trial Registries: Provide guidance in the general requirements of global registries based on internal supporting documents.

Functional Area Relationship Support: Maintain effective cross-functional relationships to maximize contribution to quality activities.

Department Operations: Assist with new or revised Registry processes to be developed.

Fulfilment of Obligations Outlined in SOPs and Other Controlled Documents.

Required Skills: Experience working in Clinical Trial Registry Management or Clinical Trial Management.

Sound regulatory knowledge, e.g.

42 CFR Part 11, FDAAA 801, EU Directive 536/2014 and ICH
• Strong understanding of global Registry requirements.

Bachelor’s degree or equivalent ideally a Life Science Degree or relevant Industry recognized qualification preferred.

Experience with systems such as PharmaCM and registries such as, EudraCT, and EU PAS are highly desired.

Scientific Knowledge.

Excellent observation, analytical thinking, and problem solving skills.

Effective communication and presentation skills, both verbal and written.

Excellent computer skills (e.g.

electronic document management systems, portals, clinical trial management systems).

Ability to work on multiple projects in a matrix team environment.

Able to work effectively independently as well as in a team environment.

Ability to demonstrate independent judgement.

Ability to travel up to 10% of time.

This 12month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: [Click Here to Email Your Resumé] ALPHA’S REQUIREMENT 19-02244 MUST BE ELIGIBLE TO WORK IN THE U.S.