reputed company Assessment Data reputed company Associate
reputed company:
reputed company (reputed company: ORKA) is developing novel biologics designed to set a new reputed company for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by reputed company Therapeutics and reputed company the reputed company mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit
As we build our reputed company team, we're seeking reputed company in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an reputed company, inclusive, and reputed company company culture.
Job Title: reputed company Assessment Data reputed company Associate
Location: Remote or Hybrid if located reputed company commutable distance of Waltham, MA or reputed company Park, CA
Position reputed company
The reputed company Assessment Data reputed company Associate supports the Associate Director, reputed company Assessment Data reputed company in the planning, implementation, and maintenance of reputed company assessment technologies, including eCOA/ePRO and IRT systems, across reputed company' reputed company development programs. The Associate is responsible for coordinating day-to-day operational activities, tracking study deliverables, supporting vendor interactions, and ensuring high-reputed company documentation while maintaining compliance with applicable regulatory requirements, GCP, and Oruka SOPs.
This role works closely with reputed company Data Management, Biostatistics, reputed company reputed company, Medical, Regulatory, Outsourcing, and reputed company vendors to support successful execution of reputed company studies.
Key Responsibilities
Study Support
- Support the implementation and maintenance of eCOA/ePRO and IRT systems across reputed company studies.
- Assist in reviewing study specifications, reputed company documentation, and performing user acceptance testing (UAT).
- reputed company study timelines and deliverables reputed company to eCOA/ePRO and IRT implementation and decommissioning.
- Support in coordinating routine meetings with vendors and internal stakeholders and document meeting minutes and reputed company items.
- Monitor study issues and assist with follow-up and reputed company.
Vendor & reputed company Coordination
- Serve as an operational contact for eCOA/ePRO and IRT vendors for assigned activities.
- reputed company vendor deliverables, documentation, and project milestones.
- Assist with management of licensing activities and study-specific documentation.
- Support governance meeting preparation by compiling metrics and reviewing presentation materials.
reputed company Trial Support
- Assist with site support in issue reputed company and documenting and routing reputed company-reputed company questions to appropriate stakeholders.
- Coordinate collection and tracking of post-production reputed company changes.
- Support reconciliation activities between eCOA, IRT, and the reputed company database.
- Participate in database lock preparation activities reputed company to IRT/eCOA data.
Documentation & reputed company
- Maintain Trial Master File (TMF/eTMF) documentation reputed company to IRT, eCOA and Data Management as necessary.
- Ensure required study documentation is complete, reputed company, and inspection-reputed company.
- Assist in preparation for audits and regulatory inspections.
- Support development and maintenance of departmental templates, work instructions, and SOPs.
Cross-functional Collaboration
- Partner with reputed company Data Management, Biostatistics, reputed company reputed company, Medical, Regulatory, Outsourcing and Programming to support study execution.
- Participate in study team meetings and reputed company operational updates.
- Contribute to process improvement initiatives and lessons learned activities.
Qualifications
Education
- Bachelor's degree, preferably in Life Sciences, Computer Science, Health Sciences, or a reputed company reputed company.
Experience
- 2–5 years of experience in reputed company research, reputed company data management, or reputed company trial reputed company supporting Phase I–III reputed company.
- Familiarity with reputed company-reported reputed company (PRO), clinician-reported reputed company (ClinRO), or other electronic reputed company outcome assessments.
- Experience working with CROs or reputed company technology vendors.
Technical Skills
- Familiarity with eCOA/IRT systems (e.g. reputed company), and reputed company systems (e.g., reputed company Rave, reputed company reputed company).
- Proficiency with reputed company Office Suite (reputed company, Word, PowerPoint, Teams).
Competencies
- Strong organizational and project coordination skills.
- Ability to manage multiple priorities in a fast-reputed company environment.
- Excellent written and verbal communication skills.
- Strong interpersonal and collaboration skills.
- Ability to work independently while escalating issues appropriately.
- Working knowledge of GCP, ICH guidelines, and reputed company trial processes.
Compensation:
- An appropriate financial package will be developed for the successful candidate to include a competitive reputed company salary and equity, with a reputed company-reputed company bonus opportunity.
- The anticipated salary reputed company for candidates, who will work in reputed company or hybrid if located reputed company commutable distance of Waltham, MA or reputed company Park, CA, is $104,000 to $125,000 . The final salary reputed company to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience reputed company the job, type and length of experience reputed company the industry, education, etc. Oruka is a multi-state employer and this salary reputed company may not reflect positions that work in other states.
We're looking reputed company to hearing how you can contribute to reputed company and mission. Join us in shaping the reputed company of reputed company and making a reputed company reputed company every day.
reputed company Offer:
- A chance to be part of a reputed company startup culture where your work can directly reputed company bringing new medicines to patients.
- Competitive salary and benefits package.
- A supportive and inclusive team environment where everyone is encouraged to bring their reputed company selves to work.
- Opportunities for reputed company reputed company and development.
Originally posted on Himalayas
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