Covance

Study level informed consent developer

Job Location(s) SG-Singapore | AU-Sydney | AU-Melbourne | NZ-AUK
Job Number
2021-61754
Job Category
Clinical Study Start Up
Position Type
Full-Time
Telecommute
No

Job Overview

Covance have supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. But we are much more than a normal CRO:
- We are also the world´s biggest Central Lab, generating more clinical trial data than all other central laboratories combined
- Our Early Phase Solutions have proved to shave off 30 % time from lead candidate to Proof of Concept
- LabCorp/Covance were the first in receiving FDA approval to perform COVID19 tests using an at-home collection kit.
 
Join us and see why Covance are uniquely positioned to offer you not only a job, but a stable, long-term international career, and why more than 90% of the top 20 global pharmaceutical companies are repeat customers.
 
THE JOB
 
We are looking to recruit a permanent, full time medical/scientific document developer who would primarily be responsible to develop study level Informed Consent Documents and other study level patient facing documents on our studies.
 
This job offers excellent professional exposure to projects in multiple therapeutic areas, client interface and work dynamics to deliver documents to be used by patients globally. It is a real opportunity for career progression in a growing global Start-up Service Department.
 
Essential Job Duties:
- Responsible for development, review, finalization, and maintenance of clinical trial documents such as informed consent form and other relevant documents
- Applies knowledge of GCP Guidelines, regulatory requirements, regulatory framework of privacy standards and biological samples standards, therapeutic area(s), and Investigational Medicinal Products (IMPs) to review and develop Informed Consent Forms (ICF) and other related documents
- Ensures that the content of Master Informed Consent Form is consistent with the corresponding protocol and fully informs the subject of all information about the research study that a potential research subject would need to know in order to decide if they want to enroll in the study.
- Ensures that the content and the scientific and medical language of the consent form can be easily understood by research participants
- Ensures that documents are written/edited in compliance with the global industry standards
- Ensures client specific guidance and requirements are included within the Master Informed consent form during development and review
- Supports the development, Review and approval of master templates to ensure effective and timely execution of protocol/site activation
- Assist/Support in development of any ancillary documents requested by study teams in relation to ICF.
- Actively remains current with industry standards, trends, and competitive intelligence on regulatory documents best practices
- Adheres to the required metrics and tools to report the outcomes to analyze performance and deliverables
- Work Closely with Quality teams in implementation of best practices
- Create, review and revise training material and plans to support the training requirements of the team.
- Ensure training resources are kept up to date with the changes in procedures.
- Generate monitoring processes to ensure that trainees are competent to perform job duties.
- Follow applicable departmental Standard Operating Procedures and Work Instructions.
- Complete all assigned/required trainings within the due dates/timelines.
- Responsible for timely and appropriate communication to all stake holders, as applicable
- Liaise with PM/Designee to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety from task assigned
IS THIS YOU?
 
As an essential member of the team, the ICF Developer is responsible for development of study level Informed Consent Forms in our clinical trials. The ICF developer work closely with project lead, medical colleagues, document reviewers and the client to maintain quality and deliver study milestones.
 
- You relish working in a fast-paced environment, on complex and demanding protocols, enabling you to develop your scientific knowledge and writing skills.
- You enjoy working in a friendly and collaborative global ICF developer team environment under a supportive line manager.
- You will expand the scope of your expertise within departmental and cross-departmental capabilities and will be able to work on ICF development as well as sponsor expertise.
APPLY NOW
Unique job with critical study-level documents, client exposure and work dynamics to engage a professional with a scientific mind and a patient centric attitude.

Education/Qualifications

- University life science degree.
- English native speaker, English bilingual speaker or super proficiency in written English language

Experience

- Relevant ICF development, patient document development or other scientific/medical writing experience
Other required work-related experiences:
- Strong knowledge of the drug development process
- Good understanding of FDA IND/NDA requirements
- Strong understanding of regulations, policies and procedures concerning the conduct of clinical trials including FDA regulations, biological samples regulations, GDPR and GCP guidelines
- Preferred previous experience in writing and editing master informed consent forms and other clinical trial related documents
- knowledge and understanding of medical terminology, Health Literacy principles is a plus
- Experience in initiating and leading cross functional deliverables is a plus
- The work requires long periods of sitting, reading, and mental concentration
- Excellent customer service/ management skills
- Computer skills with excellent proficiency in MS word
- Excellent command on English language along with written and verbal communication skills
- Ability to Influence stakeholders through insight on industry trends
- Demonstrated ability to plan, prioritize and deliver timely.
- Demonstrated ability to pay attention to detail.
- Ability to deliver consistent high quality of work.
- Ability to negotiate with others.
- Ability to mentor and train others
- Maintain cross departmental synergies
- Ability to adopt to this fast-paced, dynamic environment

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