- Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor.
- The job holder, an SME for local/regional regulations, may work with multiple vendors, drives and coordinates activities across a range of stakeholders in support of site start up delivery.
- This role liaises with the applicable team to ensure compliance, coordinates best practice solutions within region and coaches others in the more complex areas of SU. The Senior Site Readiness and Regulatory Specialist proactively anticipates and mitigates issues that could delay start up across a range of sites.
- Is the escalation point for negotiations with SUPM/SUCM's on behalf of less senior colleagues.
- Responsible for maintaining awareness of regulatory legislation, guidance and practice, ICH/GCP and relevant Sponsor requirements
- Take ownership in the preparation (collection, organization and compilation) of routine submissions filed to IRB/EC/Third body/Regulatory Authorities (e.g. INDs/CTAs) including but not limited to the preparation of study documentation such as review/summarize scientific/research documents, country application form and cover letter for sponsor review as applicable
- Complete submissions to and liaise with IRB/IEC/Third body/Regulatory Authority as applicable regarding submission/approval issues
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable)
- Perform a review of final submission documents as applicable
- Ensure appropriate systems are updated accurately and compliantly, ensuring others follow established processes
- Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required
- Mentor and coach other Site Readiness and Regulatory Operations team members
- Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable]
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
- Collect and track all the necessary documents required and perform a quality review, formatting and compilation of the final documents for effective and compliant site activation and maintenance without supervision and liaise with stakeholders as applicable in site activation related items
- When delegated by line manager, oversee and ensure quality data and audit readiness
- Participate independently and take lead (as applicable) in client meetings to proactively liaise on issues related to site activation and maintenance
- Develop project specific plans for the Site Activation component of assigned studies
- Review and approve projections and timelines to study teams, ensuring that they accurately represent the country's performance and suggests mitigation actions in agreement with line manager
- Review and approve Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by line manager
- Proactively resolve informed consent and contractual language issues plus other significant barriers to study execution with study sites
- Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual
- May take country lead role for specific projects/tasks with the applicable mentoring and supervision
- Proactively identifying, preventing and escalating to Submission Leads any risk to meeting deliverables and participate in strategy meetings to mitigate them
- Notify the Submissions Lead of hours identified as Out-of-Scope or over burn
- More than 4 years of experience in clinical development or regulatory process.
- In depth experience of applying strong knowledge of ICH, RA, IRB/IEC and other applicable regulations/guidelines. Expert knowledge of investigator start-up documents; previous interaction with operational project teams and investigative sites.
- In depth experience of issue escalation and resolution.
- Credible role model in effective communication and problem solving.
- Proven strengths managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external to the organization.
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 4 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
- Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).
-
Senior Specialist
1 day ago
Gardens by the Bay SingaporeCOMPANY DESCRIPTION · DESIGNATION : Senior Specialist (Arboriculture) · RESPONSIBILITIES · As a Senior Specialist (Arboriculture), you are expected to possess excellent management, supervisory, communication and leadership skills as well as the enthusiasm to lead a team of divers ...
-
Senior Specialist
6 days ago
Gardens by the Bay SingaporeCOMPANY DESCRIPTION · DESIGNATION : Senior Specialist (Arboriculture) · RESPONSIBILITIES · As a Senior Specialist (Arboriculture), you are expected to possess excellent management, supervisory, communication and leadership skills as well as the enthusiasm to lead a team of divers ...
-
Senior IT Specialist
1 week ago
DAISHO DEVELOPMENT SINGAPORE PTE LTD SingaporeYour moment to Rise to New Heights with us at The Westin Singapore · Join us as a Senior IT Specialist today: · Develop and maintain positive working relationships with others; support team to reach common goals; listen and respond appropriately to the concerns of other employees ...
-
Senior Specialist
6 days ago
Kopitiam Investment Pte Ltd SingaporeCOMPANY DESCRIPTION · NTUC Enterprise is the holding entity and single largest shareholder of the NTUC Social Enterprises. NTUC Enterprise aims to create a greater social force to do good by harnessing the capabilities of the social enterprises to meet pressing social needs in ar ...
-
Senior Specialist
1 week ago
Attorney-General's Chambers Singapore**What the role is** · - Senior Specialist / Specialist (MLA/Extradition) · - 2 Years Contract, International Affairs Division · **What you will be working on** · - About us · The International Affairs Division (IAD) of the Attorney-General's Chambers provides legal advice to all ...
-
Senior Specialist
4 days ago
Ambition Singapore**Job details**: · Posted 16 April 2024 · SalaryNegotiable · LocationSingapore · Job type Permanent · DisciplineFinance & Accounting · Reference271331_ · Our client is a reputable and growing MNC (Consumer sector) with strong presence across Asia. To facilitate their company gro ...
-
Senior Specialist
1 week ago
Singapore Institute of Management SingaporeSenior / Specialist, Regional Marketing · Generate leads for recruitment conversion in assigned countries. Develop effective marketing strategies, reaching out to prospective students and parents through events, marketing collaterals and campaigns.- Develop and execute marketing ...
-
Senior Specialist
2 days ago
Ambition Singapore**Job details**: · Posted 22 February 2024 · SalaryNegotiable · LocationSingapore · Job type Permanent · DisciplineFinance & Accounting · Reference271331_ · Our client is a reputable and growing MNC (Consumer sector) with strong presence across Asia. To facilitate their company ...
-
Senior Specialist
3 days ago
NodeFlair Singapore**Job Summary**: · **Salary** · S$6,700 - S$12,100 / Monthly · **Job Type** · **Seniority** · Senior Lead · **Years of Experience** · At least 7 years · **Tech Stacks** · AWS Analytics · **Job title: Senior Specialist - HH IT DnA - Technical Lead, Data Engineering** · - Opportuni ...
-
Senior Specialist
1 day ago
HYPERSCAL SOLUTIONS PTE. LTD. Singapore**COMPANY DESCRIPTION** · **RESPONSIBILITIES** · As a Senior Specialist (Arboriculture), you are expected to possess excellent management, supervisory, communication and leadership skills as well as the enthusiasm to lead a team of diverse professional arborists to manage all the ...
-
Senior Specialist
6 days ago
HYPERSCAL SOLUTIONS PTE. LTD. Singapore**COMPANY DESCRIPTION** · **RESPONSIBILITIES** · As a Senior Specialist (Arboriculture), you are expected to possess excellent management, supervisory, communication and leadership skills as well as the enthusiasm to lead a team of diverse professional arborists to manage all the ...
-
Specialist/senior Specialist
3 days ago
Sea Limited SingaporeFinance - Sea Corporate, Singapore · - Experienced (Individual Contributor) · - Sea Limited (NYSE: SE) is a leading global consumer internet company founded in Singapore in 2009. Our mission is to better the lives of consumers and small businesses with technology. · - We operate ...
-
Senior Specialist
4 days ago
MSD Singapore**Job title: Senior Specialist - HH IT DnA - Technical Lead, Data Engineering** · - Opportunity to **be a part of our dynamic Team in Singapore**: · - ** Based in Singapore**, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on The Straits Times and ...
-
Senior Specialist, IT
3 days ago
JointHire Singapore Pte Ltd Singapore**Job Title**: Senior IT Specialist · **Industry**: Retail / Merchandise · **Salary**: SGD · **Location**: Central, Singapore · **About Company**: · Our client was established in 1990 and is one of Top 100 Best Employers in Singapore. It is the regional corporate headquarters, t ...
-
Senior IT Specialist
3 days ago
US Government National Mortgage Association (Ginnie Mae) Singapore**Duties**: · As a **Senior IT Specialist (INFOSEC) (Direct Hire)**, you will: · - Maintain or support the inventory of hardware and software within the program development offices. · **Requirements**: · **Conditions of Employment**: · **Key Requirements**: · - Must be U.S. Citiz ...
-
Senior Specialist
2 days ago
TOYOTA MOTOR ASIA PACIFIC PTE LTD Singapore**Job Summary** · Enhance / Develop competitive Value Chain product & packages through understanding and meeting customers' expectations especially at the point of vehicle sale to facilitate the entry into Toyota brand and delighting the customers through the ownership journey. · ...
-
Senior Specialist
1 week ago
HIMSS SingaporeYour Challenge: · The primary purpose of this position is to provide logistics management for HIMSS APAC events including related expense and resource. Logistic management will include project planning of all logístical aspects of meetings, including high-level of focus on venue ...
-
Senior IT Specialist
2 days ago
TOYOTA FINANCIAL SERVICES SINGAPORE PTE. LTD. SingaporeEngage in effective communication with the enterprise security team to grasp security requirements. · - Implement and maintain security policies and procedures based on the business information security guideline. · - Create and maintain documentation for security policies and pr ...
-
Senior IT Specialist
3 days ago
GRANMIL HOLDINGS PTE LTD SingaporeThe Singapore EDITION is located on the west end of the Orchard commercial district and will be South-East Asia's first EDITION Hotel. This eight-storey hotel will feature 204 rooms, stylishly designed with a sophisticated flair. It will be EDITION Hotels' first ultra-luxe offeri ...
-
Senior Specialist
1 week ago
TOYOTA MOTOR ASIA PACIFIC PTE LTD SingaporeDevelop training program to enhance Used Car Business Operations in the region · - Manage and deliver Used Car Training to distributors and dealers in the region · - Develop learning infrastructure to manage and deliver learning experiences in the region including but not limited ...
Site Readiness and Regulatory Senior Specialist - Singapur, Singapore - Fortrea
1 day ago
Description
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
At Fortrea, we believe in empowering individuals who are passionate about making a difference in the field of clinical research. We offer a dynamic and collaborative environment where your expertise can flourish. Join our team as a Senior Site Readiness and Regulatory Specialist and play a pivotal role in driving the success of our clinical trials. If you're ready to take your career to the next level and contribute to groundbreaking medical advancements, we invite you to apply and become part of our innovative journey.
Job Summary:
Essential Job Duties:
Experience:
Education/Qualifications:
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.