[한국 노바티스_Local Study Team_Clinical Project Manager_Oncology BU]

Sponsor
PM
neferti
2020-08-01 09:12
조회수
41

항암제 사업부 Clinical Project Manager_ Medical Affairs Clinical Operation 포지션이 오픈 되었습니다.

지원 방법

[Job Description]

The Clinical Project Manager is the single point of contact and local study team lead for the assigned projects, including regulatory post marketing surveillance, investigator initiated trial and manage access programs. The main activities include communication with CROs, HA, CRA, CTS or In-house CRA and other key country associates such as country medical advisors to assure the delivery of high quality data in accordance with GCP, ICH and local regulations within timeline and budget. The CPM is accountable to communicate with and support relationships with clinical investigators especially studies for RMP PV studies & re-examination.

 

1. Leads assigned projects of Medical Affairs Clinical Operation team to ensure deliverables are met within the established timelines, budget, drug supply and quality/compliance standard managing CRO and internal/external stakeholders.

 

2. Manages the whole process of regulatory post-marketing surveillance or non-interventional study with full understanding of local laws/regulations regarding re-examination system to retain product licenses in Korea.

 

3. Oversees local vendor/CRO performance, including set-up activities, monitoring, budget control, study drug managements, documents aspect of governance through proper CRO selection and set SSW. And support study feasibility and lead to achieve milestone in collaboration with local/region/global medical and CRO. Ensure annual regulatory reports to be submitted to HA & IRBs as required by local regulation.

 

4. Advises on protocol and CRF from the operational side, and collection and delivery of medical advice for RWE(real world evidence) studies.

 

5. Ensures operation of managed access programs based on Novartis SOP and local laws/regulations.

 

6. Leads IIT specialists to administer, maintain and co-ordinate the paperwork of IITs in compliance with Good Clinical Practice (GCP) and relevant Novartis SOPs.

                                                                                                                                                                               Minimum requirements

Minimum 5 years experience in clinical research, in planning/executing and/or monitoring clinical trials

A project management and non-interventional studies experience preferred.

Capable of leading in a matrix environment, without direct reports

Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution

A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable

Fluent English (oral and written)

Ability to communication externally in the country native language

전체 0

전체 959
NO. 제목 작성자 좋아요 조회수 작성일
공지사항
[TransPerfect] 프리랜스 임상시험 한영 영한 번역사 모집
TransPerfect | 2020.07.20 | 추천 2 | 조회 293
TransPerfect 2 293 2020.07.20
공지사항
채용공고 게시판 포인트 공지사항
Admin_ms | 2020.04.22 | 추천 0 | 조회 692
Admin_ms 0 692 2020.04.22
공지사항
임금 체불사업주 명단 공지
Admin | 2019.10.26 | 추천 1 | 조회 2108
Admin 1 2108 2019.10.26
956
[드림씨아이에스] MWPM, MW 모집
N
admin_ju | 조회 6 2020.08.13 | 추천 0 |
admin_ju 0 6 2020.08.13
955
[ICON DOCS] CRA, PMS CRA, SSU CRA, SSU CTM 채용
N
admin_ju | 조회 4 2020.08.13 | 추천 0 |
admin_ju 0 4 2020.08.13
954
(주)엘앤씨바이오 임상시험관리 담당자 채용
N
admin_ju | 조회 7 2020.08.13 | 추천 0 |
admin_ju 0 7 2020.08.13
953
(주)메디칼엑셀런스 신입/경력 CRA 채용
N
admin_ju | 조회 5 2020.08.13 | 추천 0 |
admin_ju 0 5 2020.08.13
952
[드림씨아이에스] Training팀 Trainer 모집
N
admin_ju | 조회 5 2020.08.13 | 추천 0 |
admin_ju 0 5 2020.08.13
951
[PRA Healthsciences] - Manager of Pharmacovigilance
admin_ju | 조회 17 2020.08.12 | 추천 0 |
admin_ju 0 17 2020.08.12
950
[씨엔알리서치] LPS팀 CRA 채용
admin_ju | 조회 21 2020.08.12 | 추천 0 |
admin_ju 0 21 2020.08.12
949
[시믹코리아] Medical Writing Leader 채용
admin_ju | 조회 13 2020.08.12 | 추천 0 |
admin_ju 0 13 2020.08.12
948
[시믹코리아] Senior Medical Writer 채용
admin_ju | 조회 9 2020.08.12 | 추천 0 |
admin_ju 0 9 2020.08.12
947
[시믹코리아] CRA(I, II, Sr.) 채용
admin_ju | 조회 16 2020.08.12 | 추천 0 |
admin_ju 0 16 2020.08.12
946
[시믹코리아] PM 경력 모집
admin_ju | 조회 8 2020.08.12 | 추천 0 |
admin_ju 0 8 2020.08.12
945
[씨엔알리서치] DM팀 DMA 채용
admin_ju | 조회 11 2020.08.12 | 추천 0 |
admin_ju 0 11 2020.08.12
944
국립암센터 임상시험센터 CRA를 모집합니다.
admin_ju | 조회 39 2020.08.11 | 추천 0 |
admin_ju 0 39 2020.08.11
943
[iMediSync Inc] 임상시험관리담당 CRA 채용공고
admin_ju | 조회 24 2020.08.11 | 추천 0 |
admin_ju 0 24 2020.08.11
942
[PPC] 각 부문 신입/경력 채용 (CRA, LPS PM, DM, Biostatistician, BDA,etc,.)
admin_ju | 조회 37 2020.08.11 | 추천 0 |
admin_ju 0 37 2020.08.11
941
GCCL PM팀 임상시험 관리 경력직 모집(~2020.08.31)
admin_ju | 조회 16 2020.08.11 | 추천 0 |
admin_ju 0 16 2020.08.11
940
[ICON DOCS] CRA II - Senior, CTM 채용
admin_ju | 조회 17 2020.08.11 | 추천 0 |
admin_ju 0 17 2020.08.11
939
㈜씨씨앤아이리서치 STAT 직원 공개채용공고
admin_ju | 조회 15 2020.08.11 | 추천 0 |
admin_ju 0 15 2020.08.11
938
㈜씨씨앤아이리서치 MW 직원 공개채용공고
admin_ju | 조회 17 2020.08.11 | 추천 0 |
admin_ju 0 17 2020.08.11
937
㈜씨씨앤아이리서치 CRA 직원 공개채용공고
admin_ju | 조회 23 2020.08.11 | 추천 0 |
admin_ju 0 23 2020.08.11