Clinical Research Support Specialist
hace 7 días
Clinical Research Support Specialist (Fixed Term Contract with possibilities of renovation due to performance)
The Clinical Research Support Specialist role is responsible for implementing innovative and efficient processes utilizing company tools to ensure smooth business operations and facilitate document organization, authoring, and workflow. This position provides exposure to the regulatory clinical document content, clinical document compendium for submission, documentation analysis, and data analytics. This role will assist with the development, testing, implementation, and support of small to medium complexity tools used for requesting and capturing data for metrics, system access, and dashboard presentations.
**The Clinical Research Support Specialist will**:
Learn about the Clinical Documentation compendium and provide tracking support
Build integration and provide communication within Medical Writing Therapeutic Areas and Business Areas
Provide integration, communication, and coordination with Medical Writing partners such as Clinical Sciences and Study Management, Regulatory Content Management, Monitoring Excellence, Study Initiation, and external FSP partners
Liaises and collaborates with other functions such as BARDS, Data Management, IT to allow for the exchange of information and develop an understanding of upstream and downstream activities that may impact the medical writing tools and utilities.
Provide support to Medical Writing Subject Matter Experts (SME) through tracking, metrics, database development, collection of information, and reporting
Provide support for access to Medical Writing supporting systems via the internal service request process (e.g., authoring, and archival systems)
Recommend and participate in general process improvements for all areas associated with the processes and touchpoints of her/his activity
Support metric reporting through collection and reconciliation of data
Make recommendations for process automation
Provide training and mentoring as required
Be the primary contact for customer support of tools developed by Medical Writing Business Operations
In this role the Clinical Research Support Specialist must demonstrate the following skills:
Degree in engineering, analytics, or related discipline with experience working on innovation/process improvement strategies and business support/ administrative tasks.
**Complete fluency in reading and writing American English**: C1 Level.
Programming skills, preferably VBA and Python
Technical expertise in Microsoft Office
Project management skills
Awareness of pharmaceutical industry needs beyond clinical development.
Who we are
For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
**Employee Status**:
Project Temps (Fixed Term)
**Relocation**:
No relocation
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**: R187403
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