Careers
Epigenic Therapeutics，looking forward to your joining！
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ClinicCPM（Clinical Project Manager）
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Number of recruits：1
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Place of work：Shanghai
Responsibilities:
1. Maintain and facilitate interactions with internal functions including but not limited to Medical, Data Management, Biostatistics, Procurement, Regulatory, Pharmacovigilance and Quality Assurance, and external functions including the CROs, partners and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
2. Accountable for all activities of site related study (including feasibility) execution of assigned studies / Monitors involving start-up, execution, and close-out.
3. Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide local regulatory and legal requirement expertise.
4. Ensure adherence to applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Legend Standard Operating Procedures (SOPs), Study Plans and Guidelines, and to quality standards in conducting clinical research.
5. Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation.
6. Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with Legend research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions.
7. Responsible for identifying project specific training needs and standardizing and facilitating training solutions for monitors.
8. May participate in clinical operations quality or process initiatives.
9. Assist in the creation of Standard Operating Procedures.
10. Additional responsibilities as required.
Qualifications:
1. Master degree in medicine, pharmacy or bio-technology.
2. At least 5 years clinical site management experience in pharmaceutical industry/CRO.
3. At least 2 year clinical project management experience is preferred .
4. Thorough knowledge on clinical trial regulatory requirements.
5. Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
6. Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.
7. Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment, with experience leading projects with competing deadlines.
8. Drives continuous improvement and simplicity in process and approach and enhances agility.
9. Demonstrated business ethics and integrity.
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ClinicCRA（Clinical Research Associate）
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Number of recruits：1
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Place of work：Shanghai
Responsibilities:
1.Be responsible for the specific implementation and monitoring of clinical trials, ensuring that projects are conducted in accordance with national GCP requirements, trial protocols, and company standard operating procedures, and implementing quality control throughout the entire process.
2.Conduct comprehensive management of the assigned research centers, strictly adhering to GCP, SOP, trial protocols, and Chinese laws and regulations, and timely and completely complete the selection, initiation, routine monitoring, and closure of research centers within the project timeline.
3.Coordinate communication and collaboration with various parties involved in the trial, such as medical institutions, ethics committees, and subjects.
4.Monitor the progress of the trial, ensure that it proceeds as planned, and promptly address any issues that arise during the trial.
5.Review and organize trial documentation, including trial records, subject data, trial reports, etc., to ensure their completeness and accuracy.
6.Participate in the initiation, execution, and closure of clinical trials to ensure their smooth progress and high-quality completion.
7.Maintain close communication with the research team, provide necessary support and suggestions, and ensure the achievement of trial objectives.
8.Comply with relevant laws, regulations, and industry standards to ensure the compliance of the trial.
Qualifications:
1.Bachelor's degree or above in biomedicine, clinical medicine, pharmacy, or related fields, with professional knowledge in relevant areas.
2.More than three years of work experience as a CRA or in related fields, with a good understanding of GCP and relevant regulatory requirements.
3.Possess good communication and coordination skills, able to effectively collaborate with multiple parties.
4..Have strong problem-solving and analytical skills, capable of addressing various challenges during the trial.
5.Have good document management and organizational skills to ensure the completeness and accuracy of trial documentation.
6.Possess good teamwork spirit and professional ethics, able to withstand work pressure and maintain a positive attitude.
7.Excellent English listening, speaking, reading, and writing skills, able to read and understand English literature and documentation.
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