- Key contact person for CRAs, regional and global team in assigned study
- Develop and maintain relationships with prioritized institutions and investigators within a specific TA and in assigned studies
- Facilitates investigator site communications (e.g., newsletter, enrollment updates)
- Support TA COM on strategic site development and partnerships
- Propose innovative solutions to optimize processes
- Accountable for study timeline, quality and budget plan and delivery at country level
- Provide operational strategic input to early protocol development and study timelines
- Lead CRA team to identify, screen, evaluate and select sites partnering with quality team to ensure site qualification for a specific study participation
- Coordinate and facilitate study training planning and implementation
- Responsible for country level site activation process, timeline, risk management, contract budget approval & control
- Actively coordinates, participates and presents in AST, ISST and/or SIVs as required
- Provide input into study related vendors selection, such as vendors for quick start up, recruitment, etc., review and approve vendor payments, oversight vendor deliveries
- Coordinate and facilitate enrollment readiness including all local set-up activities, CFDA study information online registration and HGRAO submission in preparation for FPV
- Lead CRAs to develop enrollment plans ensuring appropriate risk/mitigation at each site in order to meet targets
- Provide input and/or develop and maintain country level monitoring plans as required
- Oversights monitoring intervals, SDV/SDR backlog and site compliances
- Monitoring oversight including sampling review monitoring visit reports, meetings with Study Report Reviewer Specialist and COM
- Oversight site-level data entry and query resolution
- Co-ordinate and conduct study based co-monitoring with CRAs as required
- Accountable for country level Issue Management and Protocol deviation review
- Oversight of study timeline, SDV status and data query resolution as planned Verify and approve site payment
- Lead and ensure site self check process within planned time
- Ensure timely closeout site summary and CSR stamping
- Create and maintain Country level system such as eTMF and sCTMS with completeness and high quality
- Oversee site level TMFs to ensure completeness, accuracy and updated in a timely manner
- Collaborate in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up
- Identify quality issues within the study to implement appropriate corrective action plans or escalate to appropriate level for resolution Regulations and Compliance
- Responsible for understanding and complying with all regulatory requirements, ICH/GCP guidelines
- Responsibilities include understanding and following all compliance, procurement, legal, financial and Global Medical Standards and Procedures
- Coordinate internal process of Anti-Corruption Due Diligence (ACDD) with investigators
- Responsible for site-level audit and inspection activities from clinical operation perspective
- Maintains familiarity with regulations and guidelines regarding study execution practices
- At least Bachelor's degree or equivalent work experience in a scientific or health-related field
- Minimum of 3-5 years' CRA or 2 years' country study manger or similar position working experience in Clinical Trials
- Fluent English communication in reading, writing and spoken formats
- Strong self-management and organization skills
- Project management skills
- Strong problem solving and communication skills (both verbal and written)
- Good computer Microsoft office software skills
- Need to travel periodically to ISST, comonitoring activities and potentially other scientific/regional meetings
- Need to have frequent meetings with global team out of working time.
- Strong analytical skills
- Proficiency in use of project management tools such as Excel, MS project, risk assessment and contingency planning
- Strong leadership and networking skills
- Strategic thinking
- Self-motivated and with good teamwork spirit
-
Dupont Shanghai, 中国JOB DESCRIPTION At DuPont, we are working on things that matter; whether it's providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric vehicles, or protecting workers aro ...
-
Parexel Shanghai, 中国 全职When our values align, there's no limit to what we can achieve. · Drive study performance at the sites. Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents. Provide the required monitoring visit repor ...
-
Fortrea Shanghai, 中国 全职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 techn ...
-
Fortrea Shanghai, 中国 全职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 techn ...
-
FSPx CRA I
2天前
Fortrea Shanghai, 中国 全职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 techn ...
-
FSP CRA II
5天前
Fortrea Shanghai, 中国 全职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 techn ...
-
actm
5天前
Thermo Fisher Scientific Shanghai, 中国 全职At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed ...
-
FSPx CRA I
4天前
Fortrea Shanghai, 中国 全职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 techn ...
-
Fortrea Shanghai, 中国 全职Essential Job duties · 1) The below statements are intended to describe the general nature of the job and are not intended to be an · exhaustive list of all responsibilities, skills and duties. · 2) Responsible for all aspects of study site monitoring including routine monitorin ...
-
Costing Engineer
2天前
A2MAC1 Shanghai, 中国 全职Global description: · At A2Mac1, we're a diverse group, spread across the globe, who are united by a shared set of values and goals. We're committed to performing well as individuals and in teams for the betterment of our company. · A2Mac1 has a collaborative work environment tha ...
-
Medical Manager
1周前
Galderma Shanghai, 中国 全职Description · Align with global strategies to develop China local medical strategy and tactical plan for Galderma products/portfolios, including but not limited with pre-launch preparation, post-marketing clinical trials, scientific communication, build up and maintain academic ...
-
China VEO
6天前
Lilly Shanghai, 中国 全职We're looking for people who are determined to make life better for people around the world. · Purpose: · The purpose of (Senior) Advisor – China Value, Evidence and Outcomes (CVEO) is to provide scientific support on health outcomes (HO) research activities within the medical de ...
-
Pfizer Shanghai, 中国 全职Why Patients Need You · Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure ...
-
Lilly Shanghai, 中国 全职We're looking for people who are determined to make life better for people around the world. · The purpose of (Senior) Advisor – China Value, Evidence and Outcomes (CVEO) is to provide scientific support on health outcomes (HO) research activities within the medical department as ...
-
Roche Shanghai, 中国 全职The Position · The medical lead or principle/senior clinical scientist at the Early Development (ED) department of the China Innovation Center of Roche (CICoR) is responsible for providing medical/clinical expertise in the early clinical development strategy of a CICoR governed ...
-
Goodyear Shanghai, 中国Location: CN - Shanghai · Goodyear Talent Acquisition Representative: Amelia Li · Sponsorship Available: No · Relocation Assistance Available: Yes · Primary Purpose of the position · The Intelligent Manufacturing Manager - will collaborate with Global Engineering and Process ...
-
Bristol Myers Squibb Shanghai, 中国 全职Working with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
PSI Shanghai, 中国 全职Job Description · The Senior Data Manager will be responsible for oversight of all data management activities in large, complex studies. · Communication · Provide general oversight on all Data Management activities on large complex global studies · Communication line for client ...
-
Reinsurance Group of America Shanghai, 中国Responsibilities · Complete regular and ad-hoc experience study in cooperation with Data Administration and Pricing team. Ensures experience study works are appropriately documented with well control, and assists with identifying changing requirements and adapting to maintain co ...
-
BASF SE SHANGHAI, 中国- Lead the implementation of regional LCA modelling for Battery Cathode Active Materials (CAM) according to relevant standards, including ISO 14067, GBA rulebook and PEFCR for the EU Battery Regulation; · - Commission and lead LCA studies on battery CAM production, project manage ...
Manager-Country Study Management - Shanghai, 中国 - Lilly
描述
We're looking for people who are determined to make life better for people around the world.
Job Description of Country Study Manager
The Country Study Management (CSM) is responsible for providing clinical operational expertise to internal and external customers through ownership of country level study operation. The CSM will drive country initiation activities, enrollment targets and be responsible for country level quality oversight and timely delivery of country level study deliverables. The CSM will also contribute ideas to improve processes and manage change while supporting ongoing business objective.
Primary Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared.
The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Collaboration and Communication
Business Deliverables
Lead Country level feasibility
BASIC QUALIFICATIONS:
Other Information/Additional Preferences:
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly
