Job details
Salary $40 - $53 an hour job type contract
Full job description
100% remote! immediate opening for clinical quality improvement specialist to join mid-size pharmaceutical company that is rapidly growing!
Description:
As a member of the gcp quality improvement team, this position provides administrative and project management support to the process managed within the gcp quality management lead groupThis position will manage the clinical review committee (crc) process and investigator usability databaseThe specialist will manage the qml team mailbox to ensure timely management of issue entry and document distributionThe specialist will manage ssn cases (investigations, root cause analysis, and capa management) as assignedIn addition, a key responsibility of this individual is to serve as a business administrator for the electronic quality management system (eqms).
Manages the crc and liaises with cross-functional crc members to ensure timely review and approval of documents to support clinical trial timelines
Supports the suspected serious noncompliance (ssn) process by managing the qml team mailbox to ensure issues are entered in veeva eqms and documents and queries are handled appropriately and in a timely
Manages the investigator usability database within the veeva eqms to ensure the list is current and accessible; provides technical support on the use of the database to all global development (gd) employees
Maintain files that support the crc, issues, and investigator usability processes overseen by the global development quality
Function as a business administrator and expert user for the veeva eqms
Manage ssn cases (investigations, root cause analysis, and capa management) as assigned
Supports closure of capa action items
Supports the quality risk assessment and control tracker (qract), spsv process, and protocol deviation trending process as assigned
Additional skills & qualifications:
Bachelors degree
4+ years of relevant industry or clinical research experience
2+ years’ experience working in either a clinical compliance group, qa quality management/quality risk management function, or clinical development with expertise and/or transferrable skills with good clinical practice and regulatory inspections.
Excellent communication skills and ability to work with people in all levels of the organization and externally.
Excellent technical skills; prior experience with veeva eqms
Demonstrated skills in taking initiative and working independently
Self-motivated with the ability to work effectively in a dynamic environment with ambiguity
Strong leadership with demonstrated ability to interface with sr leaders
Good problem solving, written and verbal communication skills
Ability to effectively manage multiple priorities with a sense of urgency
Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
Compensation is tied the colorado market for job performed in coloradoOther locations may be subject to variances based on locations-related factorsWe reserve the right
To pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classificationEligibility requirements apply to some benefits and may depend on your job classification and length of employmentBenefits are subject to change and may be subject to specific elections, plan, or program termsThis temporary role may be eligible for the following:
Medical, dental & vision
401(k)/roth
Insurance (basic/supplemental life & ad&d)
Short and long-term disability
Health & dependent care spending accounts (hsa & dcfsa)
Transportation benefits
Employee assistance program
Time off/leave (pto, vacation or sick leave)
About actalent:
Actalent connects passion with purposeOur scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve moreEvery day, our experts around the globe are making an impactWe’re supporting critical initiatives in engineering and sciences that advance how companies serve the worldActalent promotes consultant care and engagement through experiences that enable continuous developmentOur people are the differenceActalent is an operating company of allegis group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
