We are currently seeking a
Clinical Document Control Specialist
to support our team. This position will work in Houston.
This position will work in Houston, Texas and responsible for filing and quality data control of auditable regulatory document filing in the eTMF for clinical trials. Will support data clean up efforts, system configurations and documentation, as well as technology-related inventory management
The main responsibilities of this position will include but are not limited to the following tasks:
- Provides ownership of the trial master files (TMF) for multiple clinical trials.
- Serves as a super user of the electronic trial master file (eTMF) system.
- Prepares, processes and tracks clinical documents received in a timely manner as per project guidelines.
- Log information into internal tracking system (e.g. CTMS and eTMF).
- Improves the overall quality, completeness and accuracy of clinical documentation by performing open record reviews using clinical documentation guidelines.
- Review of the Trial Master File in preparation for audits and TMF quality reviews.
- Remains current in regulatory requirements, industry standards and best practices in the area of clinical documentation and trial master file management.
- As needed, serves as a member of implementation team for new systems.
The qualifications for this position include, but are not limited to the following:
- A Bachelor’s degree in the biomedical sciences or related field with a strong interest in clinical research.
- A Minimum of 2 years of direct experience with filing in an eTMF in a regulated clinical research environment. Similar experience in Quality Assurance or paper TMF filing may be considered.
- Working knowledge of standardized TMF taxonomy (DIA Reference Model).
- Prior experience in design and implementation of eTMF system(s) Preferred.]
- Understanding of Good Clinical Practices.
- Strong team player
- Proven ability of coordination and planning of tasks and time management.
- Analytical reasoning.
- Excellent verbal and written communication skills.
- Ability to prioritize and adapt quickly in a fast-paced and changing industry.
- Ability to recognize potential obstacles and work within set timelines.
- Self-motivating and able to prioritize and take initiative.
- Ability to make informed decisions based on guidance from manager and take responsibility for actions.
- Open minded for rapidly changing requirements.
What We Offer
We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits – e.g. job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.
We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills. Immatics offers partial subsidized health, dental and vision insurance, 401(k), 160 hours of PTO annually, paid holidays, paid parking, paid short/long term disability/AD&D and life insurance.
If you’re interested in working for Immatics, please forward your CV along with a letter of introduction via e-mail to RecruitingUS@immatics.com. For more detailed information about Immatics and privacy protection visit www.immatics.com.
Notice to Third-Party Recruiters/Staffing Agencies: Recruitment is managed through Immatics US’ Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Immatics US, and no fee/payment will be paid. Recruiters interested in working with Immatics US can submit their information to HR-US@imamtics.com, and we will contact you if needed.