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 Senior Documents Specialist is responsible for providing support to the TMF content owners (both internal and external) on one or more clinical programs. This position will work closely with the Project team to ensure that the TMF is kept both current and inspection ready.
Essential functions of the job include but are not limited to:
- Prepare TMF plans for assigned studies
- Meet with the Study team to establish the list of required study documents, country/site list and current site contacts
- Configure the study within the eTMF to the specifications provided by the study team
- Provide TMF support to clinical trial activities conducted by Precision
- Monitor TMF status and run metric reports monthly to distribute to the study team
- Train and mentor junior clinical document specialists in the performance of TMF responsibilities
Qualifications:
Minimum Required:
- 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline
- Minimum 4 years of 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!
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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].
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