Precision for Medicine is hiring a Senior Document Specialist (eTMF) to join our TMF team. This role will be working remotely and can be based in one of the following locations: Hungary, Poland, Serbia, Romania or Slovakia.
Position Summary:
The Documents Specialist is responsible for preparing TMF plans, document QC and indexing in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate.
This is Document Specialist II level (Senior or Principal levels may be considered depending on experience).
Essential functions of the job include but are not limited to:
- Perform document QC and indexing within eTMF for assigned studies (TMF Lead tasks as required)
- Monitor document submission and timely document process, to avoid developing a backlog; escalate as needed to eTMF Management for support
· Distribute TMF metrics
- Follow-up on document in clarification and ensure these are resolved timely
- Manage the close-out activities of assigned studies, including timeline for final document submission, wrap up of document processing, close out of all documents in close-out, requesting the eTMF export, transfer to the Client and get the Acknowledgement of Receipt.
Qualifications:
Minimum Required:
- Degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline
· Previous clinical trial experience
- Previous experience with TMF and/or eTMF
Other Required:
- Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
- Ability to speak English proficiently (professional level)
Competencies:
- Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
- Demonstrates solid interpersonal skills
- Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders
- Communicates both verbally and in written form in an efficient and professional manner
- Demonstrates values and a work ethic consistent with Precision Values and Company Principles
At Precision for Medicine, we believe that the era of one-size-fits-all medication is giving way to a next generation of treatments, medicines that will be more effective because they are prescribed according to the unique biology of an individual patient. Our mission is to help innovative biotech and pharmaceutical companies accelerate the development of these life-changing treatments. Precision does this by developing assays that utilize biomarkers to help identify the right patient for the right drug. We handle every aspect of clinical trials from initial strategy and design to selecting sites and executing quality clinical trials. This is where you come in!
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
Poland
