Description
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 Innovative Medicine and MedTech, 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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
R&D OperationsJob Sub Function:
Clinical Trial SupportJob Category:
ProfessionalAll Job Posting Locations:
Seoul, Korea, Republic ofJob Description:
An Associate, Site Manager is an entry level site management role with typically 0-2 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. An Associate, Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Associate, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training. Some supervision from a more Senior, Site Manager (Senior SM or Lead SM) to help provide guidance to Associate, Site Manager.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Clinical Research Associate (Associate Site Manager).
Position Summary:
An Associate, Site Manager is an entry level site management role with typically 0-2 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. An Associate, Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Associate, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training. Some supervision from a more Senior, Site Manager (Senior SM or Lead SM) to help provide guidance to Associate, Site Manager.
Principal Responsibilities:
- Acts as primary local company contact for assigned sites for specific trials.
- May participate in site feasibility and/or Site Qualification Visit.
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring, and close-out according to SOPs and policies.
- Ensures site staff are trained and training records are complete and accurate.
- Contributes to site level recruitment strategy.
- Ensures site study supplies are adequate.
- Ensures clinical drug supplies are used and documented appropriately.
- Arranges for destruction of clinical supplies.
- Ensures data entry and query resolution within timelines.
- Ensures accuracy and completeness of data collected.
- Ensures AE/SAE/PQC reporting compliance.
- Maintains complete and accurate trial data and documents.
- Fully documents trial related activities and monitoring reports.
- Ensures archiving requirements are met.
- Collaborates with LTM for site/study progress.
- Participates in meetings and trainings.
- Develops therapeutic and protocol knowledge.
- Supports CAPA for QA audits.
- Prepares and conducts site close-out.
- Tracks site costs and payments.
- Maintains relationships with stakeholders.
- Supports HA and IRB submissions.
- Acts as point of contact for site management practices.
- Contributes to process improvement.
Principal Relationships:
- Primary Reporting Structure: Reports to a FM/CRM
- Primary interfaces: FM/CRM, CTA, LTM and TDL
- Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Compliance Managers/Specialists, Training Manager, Contracts & Centralized Services (CCS), Local Safety Officer (where required) and Site Manager team.
- External Interfaces: Investigators and their delegates at site (trial site personnel).
Education and Experience Requirements:
- A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related field
- A minimum of 1 year of clinical trial monitoring experience is required (1-2 years preferred)
- Basic knowledge of GCP, SOPs, and regulations
- Strong IT skills
- Willingness to travel
- Proficient in local language and English
#LI-Hybrid
Legal Entity
Innovative Medicine
Job Type
Regular
Application Documents
Free-form resume AND cover letter is preferred (in Korean or English).
Application Deadline
Open until the position is filled.
Notes
- Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.
- Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.
- If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.
- Submitted documents will not be returned and will be deleted upon request.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time ManagementAbout Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Clinical Research Associate (Associate Site Manager).
Position Summary:
An Associate, Site Manager is an entry level site management role with typically 0-2 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. An Associate, Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Associate, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training. Some supervision from a more Senior, Site Manager (Senior SM or Lead SM) to help provide guidance to Associate, Site Manager.
Principal Responsibilities:
- Acts as primary local company contact for assigned sites for specific trials.
- May participate in site feasibility and/or Site Qualification Visit.
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring, and close-out according to SOPs and policies.
- Ensures site staff are trained and training records are complete and accurate.
- Contributes to site level recruitment strategy.
- Ensures site study supplies are adequate.
- Ensures clinical drug supplies are used and documented appropriately.
- Arranges for destruction of clinical supplies.
- Ensures data entry and query resolution within timelines.
- Ensures accuracy and completeness of data collected.
- Ensures AE/SAE/PQC reporting compliance.
- Maintains complete and accurate trial data and documents.
- Fully documents trial related activities and monitoring reports.
- Ensures archiving requirements are met.
- Collaborates with LTM for site/study progress.
- Participates in meetings and trainings.
- Develops therapeutic and protocol knowledge.
- Supports CAPA for QA audits.
- Prepares and conducts site close-out.
- Tracks site costs and payments.
- Maintains relationships with stakeholders.
- Supports HA and IRB submissions.
- Acts as point of contact for site management practices.
- Contributes to process improvement.
Principal Relationships:
- Primary Reporting Structure: Reports to a FM/CRM
- Primary interfaces: FM/CRM, CTA, LTM and TDL
- Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Compliance Managers/Specialists, Training Manager, Contracts & Centralized Services (CCS), Local Safety Officer (where required) and Site Manager team.
- External Interfaces: Investigators and their delegates at site (trial site personnel).
Education and Experience Requirements:
- A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related field
- A minimum of 1 year of clinical trial monitoring experience is required (1-2 years preferred)
- Basic knowledge of GCP, SOPs, and regulations
- Strong IT skills
- Willingness to travel
- Proficient in local language and English
#LI-Hybrid
Legal Entity
Innovative Medicine
Job Type
Regular
Application Documents
Free-form resume AND cover letter is preferred (in Korean or English).
Application Deadline
Open until the position is filled.
Notes
- Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.
- Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.
- If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.
- Submitted documents will not be returned and will be deleted upon request.
