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Join Us for Creating a Better Life!

We have always been committed to excelling in clinical trials to benefit our clients and patients around the world. We invite you to join us along the path of globalization.
– Competitive compensation & benefits
– Collaborative and inclusive working environment
– Attractive career advancement

 

Recruitment Locations

Europe:

Ireland,Belgium, Denmark, Finland, Sweden, Norway, Slovakia, Portugal, Switzerland, UK, Germany, Greece, Hungary, Ukraine, Italy, Netherlands, Poland, Bulgaria, Czech Republic, Spain, France, Russia

America:

Mexico, Colombia, Chile, Argentina, Peru, Brazil, US, Canada

Asia:

Pakistan, Sri Lanka, Indonesia, Philippines, Thailand, Vietnam, Taiwan China, Malaysia, Singapore, India

EMEA:

Israel, UAE, Saudi Arabia, Turkey, South Africa

Oceania:

Australia, New Zealand

 

Position: SCRA

Job Purpose

a) This position is responsible for project management and study site management from site selection to initiation until monitoring and close out of assigned clinical study in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH GCP), Clinical Practice standard (GCP) and other applicable regulations.
b) The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

Responsibilities

ROLE1: Project Team Leadership and Management
a) Planning
• Planning of project activities and study timelines based on project goal and sponsor’s expectation.
b) Implementation
• Organize and Lead meeting/teleconferences for study activities implementation (e.g. investigator meeting, project review meeting etc ), monitoring the progress of each CRA responsible sites, and assessing overall status of the project.
• Develop the project management plan, monitoring plan etc as required for the study.
• Develop study specific tools/forms, study templates as required for the study.
• Develop and manage project budget.
• Order and ensure all clinical supplies (including drug and non drug) are adequate for all sites throughout the study period.
• Ensure all team members have timely access to appropriate systems and tools, if applicable (e.g. IVRS, eCRF etc.)
• Organize and conduct site feasibility visits according to guidelines and make recommendation for final approval.
• Coordinate the application of specimen export permit, if applicable.
• Maintain and manage all project trial master files throughout the study period and coordinate the long term archiving and handover to sponsor at the end of the study.
• Conduct the co visit at site with CRA according to Tigermed SOP.
c) Tracking
• Track study progress and ensure project is conducted according to the plan.
d) Communication
• Communicate to monitors new study information, study timelines and goals, study requirements.
• Responsible for raising overall project specific issues to management (e.g. Project Director, Senior Management).
• Submit the weekly project report to management (e.g. Project Director, Senior Management).
• Communicate to sponsor study status and key issues.
• Generate monthly project status report to sponsor.

ROLE2: Study Implementation
a) Site management
• Study site selection, initiation (SIV) and clinical monitoring.
– Perform pre study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.
– Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.
– Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH GCP and GCP.
– Track study recruitment to ensure recruitment target is achieved in all studies.
– Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner
coordinating.
– Ensure timely coordination of study materials (drug, non drug, equipment’s, CRFs) to the site for start up and throughout the study.
– Assemble site specific EC submission dossier, and ensure submission to EC.
• Training
– Provide ongoing training to site staff with regards to ICH GCP, GCP, study protocol and requirements.
– Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.
• Documentation
– Ensure timely collection of essential documents in compliance with protocol and regulations at study start up, during and at study close down. Maintain and update these documents in investigator files, trial master files.
– Prepare/complete study records’ archiving according to protocol and sponsor requirements.
b) Drug Safety
• Ensure safety information is disseminated to all sites according SOP and applicable regulations.
• Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.
c) Finance Administration
• Finalize budget and obtain signed contract from site, prior to site initiation visit.
• Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
d) Study Tools and system
• Update and maintain Study tools/systems in a timely manner

ROLE3: Mentoring
a) Provide guidance and training to entry level CRA/CRA I/CRA II in collaboration with Line Manager.

Minimum Qualifications

a) Academic/Major
Bachelor degree or above in Medical, Pharmacology or Biology related major. College diploma can be accepted if the personal attributes and relevant project management experience are sufficiently justified.
b) Professional Skills
Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/ procedures. Good organization skills. Good working and proactive attitude. Value importance of teamwork. Ability to work independently .
c) Work Experience
At least two years and a half (for CRA with master degree or above) or three years of CRA experiences. Or qualified enough being assessed by LM with more than four years clinical research related experience or more than two years of clinical research management activities. Work experience on previous position at least 1 years
d) Language ability
Fluent in both written and spoken English Local languages fluency is preferred.
e) Computer Literacy
Excellent command of Microsoft offices.
f) Other abilities such as communication skill Information analysis skill. Knowledge and/or experience in medical practice is a plus.

Please forward your CV to the following email if you are interested in these positions: Jing.yu@tigermedgrp.com

 

Position: Senior PM

Job Purpose

To draft and implement project management effectively, and clinical operation conducting for related projects to insure that clinical research affaires works smoothly.

Responsibilities

a) Acts as the primary liaison for the sponsors of the responsible studies
• Understands/manages/satisfies sponsor contractual, organizational and relationship needs/expectations
• Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plans to the sponsors
• Chairs and leads sponsor meetings
b) Leads and directs cross functional team leaders and third parties/vendors
• Sets up project plans (multi service plan including PMP, Risk Management Plan, MP and communication plan)
• Defines metrics for reporting performance against projection
• Ensures all standard project systems and tools are set up correctly and function appropriately
• Implements operational strategies as defined in the project plans and regularly reviews and revises the plans to ensure desired outcome
• Identifies best practices learnt during projects and shares across the organization
• Guides and supports team members in identifying and analyzing risks, prioritizing, trouble shooting and contingency planning
• Delegates whilst retaining ownership
• Communicates project specific priorities
• Liaises with functional leads/managers to optimize performance and utilization of project team members
• Establishes team goals, inspires individual ownership, and establishes processes to support project result accountability Leads internal monthly project review meetings
c) Manages project contractual deliverable in terms of project milestone payments and quality insurance
• Establishes project plans including timelines, monitoring, resource, risk/contingency and quality planning
• Establishes quality standards for the projects and drives individual and team commitment ensure quality is met Monitors quality of deliverables and implements corrective and preventative action as needed
• Participates in site selections, initiations, monitoring, and closeout activities
• Manages project progress via metrics and proactive communication
• Monitors and ensures adherence to the contractual agreement (quality/scope, and cost deliverables)
• Leads internal project status reviews and be accountable for action items follow up
• Proactively identifies, resolves/mitigates and escalates risks and/or issues
• Close out of all project activities upon project completion performs financial reconciliation and system closeout
d) Manages project scopes and project costs timely to ensure control of project financial risk
• Owns projections of units/hours (revenue and resources), actual units/hours efficiency analysis
• Proactively and timely identifies, negotiates and executes contract modifications for assigned projects, ensuring out of scope activities are
approved upfront via contract modification
• Identifies potential or actual unrecoverable hours and provides analysis and mitigation/resolution plan for senior management’s approval
• In cooperation with BD and Finance departments, applies efficient management of project pass through costs and investigators payments to ensure all such costs are recovered in a timely manner, and in advance whenever possible
• Leads project financial reviews and be accountable for action items follow up
• Ensures timely invoicing for milestones achieved
e) Ensures adherence to company SOP, policies and guidelines at the project level
f) Ensures projects comply with Tigermed processes and systems such as CTMS, OA, eTMF etc including escalation to relevant functional and operational management
g) Participates and attends bid defense process
h) Perform necessary training for Project Supervisor/Project Manager and build the effective team
i) Provides feedback on project team member’s performance to respective line managers

Minimum Qualifications

a) Academic/Major
Bachelor degree or above in Medical, Pharmacology or Biology related major. College diploma can be accepted if the personal attributes and relevant project management experience are sufficiently justified.
b) Professional Skills
Adequate knowledge of current drug development processes and regulations, including local regulations, GCP, clinical trial operations. Current GCP certificate required. Business skills such as budgeting and business knowledge are a bonus.
c) Work Experience
A minimum of 10 years industry experience, including a minimum of 6 years project management experience, CRO work experience preferred. If outstanding PM achievement is shown, suitable candidate will be considered.
d) Language ability
Fluent in both written and spoken English Local languages fluency is preferred.
e) Computer Literacy
Excellent command of Microsoft offices.
f) Other abilities such as communication skill Information analysis skill. Strong project management skill; Strong time management skill.

Please forward your CV to the following email if you are interested in these positions: Jing.yu@tigermedgrp.com