핵심 정보
- 경력
- 경력 4년 ↑
- 학력
- 대졸(4년제) 이상
- 근무형태
- 정규직 수습기간 3개월
- 우대사항
-
- 전공생명/환경공학, 간호학
- 외국어 능력영어능통자
- 활동/경험해당직무 근무경험
- 급여
- 면접 후 결정
- 근무지역
- 서울 용산구
상세요강
At
Johnson & Johnson, we believe health is everything. Our strength in
healthcare innovation empowers us to build a world where complex diseases are
prevented, treated, and cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in pharmaceutical, medical
devices and diagnostics markets, we are uniquely positioned to innovate across
the full spectrum of healthcare solutions today to deliver the breakthroughs of
tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ .
DE&I
Statement
For
more than 130 years, diversity, equity & inclusion (DEI) has been a part of
our cultural fabric at Johnson & Johnson and woven into how we do business
every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a
healthier, more equitable world. Our diverse workforce and culture of belonging
accelerate innovation to solve the world’s most pressing healthcare challenges.
We
know that the success of our business – and our ability to deliver meaningful
solutions – depends on how well we understand and meet the diverse needs of the
communities we serve. Which is why we foster a culture of inclusion and
belonging where all perspectives, abilities and experiences are valued and our
people can reach their potential.
At
Johnson & Johnson, we all belong.
1.
포지션:
Senior Project Manager (Local Trial Manager)
2.
계열사:
얀센
(Janssen)
3.
근무지:
서울시
용산구
4.
근무
형태:
Regular
[Summary]
The
Local Trial Manager III (LTM III) is responsible for local management of a
clinical trial (or Medical Affairs data generation activity) in a country or
countries. The LTM III is the primary point of contact at a country level for
assigned studies and has operational oversight of assigned protocol(s) from
start-up through to database lock and closeout activities as described in GCO
procedural documents. The LTM III is responsible for coordinating and leading
the local trial team to deliver quality data and trial documents/records that
are compliant with the assigned clinical trial protocol, company Standard
Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory
requirements.
The
LTM III role actively leads or contributes to process improvement: training and
mentoring of other LTMs and Site Managers (SM).
Compared
to LTM I and LTM II roles, an LTM III is often assigned to more complex
protocols and can work across Phase 1 – 3 studies in multiple therapeutic areas
as needed to drive business needs.
The
LTM III may also perform the role of Clinical Trial Manager (CTM)/Global Trial
Lead (GTL) for single country as described in GCO procedural documents.
[Essential
duties and responsibilities]
1.
Collaborate with FM/CRM for country protocol feasibility (if applicable) and
site feasibility assessment in conjunction with CTA (if applicable), SM and
CTM/GTL. Implements any local criteria for site selection. Ensure consistent
conduct of pre-trial assessment visits and instruct teams on appropriate
follow-up of pre-trial visit report and country feasibility report. Recommends
suitable sites for selection to participate in trial.
2.
Collaborates with the Global Project Lead (GPL), Clinical Trial Manager
(CTM)/Global Trial Lead (GTL), local management/Country Head and other study
team member to select final site list.
3.
Contributes input to the study management documents at a country level or
initiates development of these documents for a single country trial, as per
SOPs.
4.
Leads and coordinates local trial team activities in compliance with GCO
Standard Operating Procedures (SOP), other procedural documents and applicable
regulations. Leads local project planning activities to meet recruitment
targets and to deliver high quality data on time and within study budget.
Including but not limited to: development of local trial specific procedures
and tools, recruitment planning, contingency and risk management, and budget
forecasting.
5.
Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product
Quality Complaints (PQCs) are reported within the required reporting timelines
and documented as appropriate.
6.
Maintains and updates trial management systems. Uses study tools and management
reports available to analyze trial progress.
7.
Monitors country progress and initiates corrective and preventive actions
(CAPA) when the trial deviates from plans and communicates study progress and
issues to study management teams.
8.
May submit requests for vendor services and may support vendor selection
9.
In certain situations, may assist in negotiation of trial site contracts and
budgets. Forecasts and manages country/local trial budget to ensure accurate
finance reporting and trial delivered –within budget. Adheres to finance
reporting deliverables and timelines.
10.
Attends/participates in Investigator Meetings as needed. May schedule and
conduct a local/country investigator meeting.
11.
Conducts local trial team meetings and provides or facilitates SM training when
needed (i.e. implementation of study amendment-and changes in study related
processes).
12.
Reviews and approves Monitoring Visit Reports submitted by SM; identifies
issues and/or trends across a trial project and escalates deviation issues to
the CTM/GTL and FM as needed
13.
Reviews and approves site and local vendor invoices as required. Manages local
study supply, as required.
14.
Prepares country specific informed consent in accordance with GCO procedural
document/templates. Reviews and manages site specific informed consent forms in
accordance with GCO SOPs, other procedural documents and applicable
regulations.
15.
Organizes and ensures IEC/HA approvals, if applicable, and ensure that the
trial is compliant with local regulatory requirements.
16.
Works with SM to ensure CAPA is implemented for audits and inspection or any
quality related visits
17.
Complies with relevant training requirements.
18.
Acts as subject matter expert for assigned protocols. Develops strong
therapeutic knowledge to support roles and responsibilities. May represent
Global Clinical Operations on cross functional teams.
19.
Acts as primary local/country contact for a trial. Establishes and maintains
excellent working relationships with external stakeholders, in particular
investigators, study trial coordinators and other site staff; and internal
stakeholders, including Medical Affairs and Marketing for Medical Affairs
trials.
20.
Conducts accompanied site visits with SM as delegated by FM.
21.
Contributes to process improvement.
This
is not an exhaustive, comprehensive listing of job functions. May perform other
duties as assigned.
[Requirement]
Principal
Relationships:
Primary
Reporting Structure: Reports to a Functional Manager
Primary
interfaces: Functional Manager/CRM, CTAs, SMs, CTM/GTLs, Study Responsible
Physicians (SRP), Quality & Compliance Managers/Specialists, Local Safety
Officer
Other
Internal Interfaces: R&D Country Head, Regional Therapeutic Area Experts
(RTAEs), Contracts & Grants, CTM/GTL, R&D study team (e.g., SRP), data
management and Medical Affairs (when applicable)
External
Interfaces: Trial Site Personnel, external vendor representatives, Ethics
Committee and others as required.
Education
and Experience Requirements:
- A minimum
of a BA or BS degree in Life Sciences, Nursing or related scientific field
(or equivalent experience) is required.
- Minimum
of four years of pharmaceutical and/or clinical trial experience is
preferred (including site monitoring experience), however, other relevant
experiences and skills may be considered by the hiring manager when
considering the candidate’s eligibility.
- Specific
therapeutic area experience may be required depending on the position.
Should have solid understanding of the drug development process including
GCP and local regulatory requirements. Willingness to travel with
occasional overnight stay away from home.
- Strong
leadership skills. Solid communication and computer skills required.
Proficient in speaking and writing the country language and English
language. Excellent written and oral communication skills
- Strong
experience in mentoring/coaching and providing training to other LTMs, SMs
and CTAs. Demonstrated ability to lead initiative/small teams.
- Flexible
mindset and ability to work in a fast-changing environment. Ability to
work on multiple trials in parallel in different disease areas, if
required.
[JD 확인 및 지원 방법 ]
https://careers.jnj.com ->
Requisition number “2406196568W”검색 -> 해당 모집 공고 클릭 후,
“Apply Now”
[ 제출 서류 ]
영문 자유 양식의 이력서/경력기술서/자기소개서
[ 서류 마감일 ]
채용시 마감
[ 유의사항 ]
-
국가보훈
대상자
및
장애인은
관련
서류
제출
시
관계
법령에
의거하여
우대합니다.
-
서류
전형
합격자에
한하여
개별
통보합니다.
단,
회사
사정에
따라
지연될
수
있습니다.
-
입사
지원
서류에
허위
사실이
발견될
경우,
채용
확정
이후라도
채용이
취소될
수
있으며
향후
채용이
제한됩니다.
-
제출된
서류는
반환되지
않으며,
별도
요청
시
삭제합니다.
www.careers.jnj.com
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