Study Management Specialist

Purpose
Manage and Lead a project on all aspects of design planning startup conduct analysis
reporting and closeout of assigned NIS including regulatory PMOS IIS and PAA. Responsible for managing planning timelines milestone budget study sites vendors and deliverables while maintaining quality and compliance.

Responsibilities

Provide comprehensive input to study concept development especially operational point of view
Develop study protocol/protocol amendment and CRF and get approval from GUS-RC or ARC and MFDS(if applicable) by managing multidisciplinary assessment.
Develop and provide official answers to MFDS by collecting and analyzing reference/data regarding supplementary comments from MFDS (protocol annual report re-examination report) for regulatory PMOS
Review and finalize CSR according to SOP and local regulation by coordinating and complying with all internal processes and approvals as well as MFDS
MFDS point of contact: Communicate/Negotiate with MFDS on protocol/protocol
amendment study implementation or issue for regulatory PMOS
Study project management: Accountable for all aspects of project management including study plans operation coordination timelines problem identification and resolution communication with stakeholders status reports and budget forecasting/planning CRO management to reach the milestone and to ensure timely delivery of completed study reports

o Responsible to supervise daily operations and management of activities associated with assigned project(s) from concept to completion of final study report and ensure project goals are achieved
o Lead project start-up activities such as vendor evaluation bidding selection set-up and training as well as study site evaluation and selection
o Manage and steer vendors including CROs to perform studies as planned
o Acts as a liaison with internal and external stakeholders regarding study update issue escalation study specific information etc.
o Develop study budget plan forecasting review reconciliation. Manage project specific budget by monitoring and adjusting current study status as well as evaluating FMV and ensuring investigator payments occur in a timely/compliant manner
o Ensure effective project plans are in place and lead the project proactively with relevant stakeholders communication and to set priorities in accordance with applicable project plans
PAA (Pre-Approval Access Program): Manage and conduct PAA with regards to IP supply
IP importation IP destruction as well as communication with MFDS HQ vendor and investigators
For PAA if applicable develop essential documents such as protocol informed consent
and get approval from GUS-RC or ARC and MFDS as well as filing documents to MFDS
For IIS (Investigator Initiated Studies) manage and oversight as an operational point such as coordinate and support concept/protocol review and approval from all kinds of Review Committee (Affiliate Global Area) FMV assessment managing agreements documents milestones (progress) payments and issues
Assure full compliance with GCP Global & local SOPs and Korean regulations

Qualifications :

PREFERRED QUALIFICATIONS
University degree or equivalent; preferably in a medical/science-related field or equivalent work experience in a scientific or health-related field
Minimum 5-year experience in clinical research in healthcare pharmaceutical and/or CRO
industry or minimum 3-years direct experience as a project manager
NIS experience is preferred
Fluent English communication skills (Reading writing speaking)
Good understanding of clinical trial processes AbbVie internal processes and the regulatory environment as well as strong knowledge of clinical research practices local regulations and ICH guidelines
Familiarity of AbbVie policies & procedures and local SOPs
Strong computer/technology skills including MS Word MS Excel and PowerPoint
Fluent English communication skills (Reading writing speaking)
Possess strong project management time management and coordination skills with good
organizational leadership negotiation and interpersonal skills
Strong analytical and problem-solving capabilities with sense of responsibility
Manage conflict challenges decision making and risk management as a project manager
Ability to manage time/prioritize multitask work independently self-motivated and
follow through with assigned tasks
Excellent written and verbal communication skills demonstrated by the ability to present
clear messages from complex information/data to internal/external stakeholders

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time