PRIMARY DUTIES:

Management of clinical research project in China

Vendor (CRO, Lab, drug storage, etc.) supervision and management to ensure quality and timelines

Liaison with KOLs and support scientific meetings and publications

Support IND and NDA filing

Quality control of the clinical research projects, such as co-monitoring visit

RESPONSIBILITIES:

Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.

Provide leadership in clinical trial conduct, including but not limited to CRO and site selection and activation, protocol implementation and quality control, management of project progress and timelines.

Review and approve study documents, e.g., site feasibility survey, ICF, CRFs, protocol, CSR, etc.

Prepare Monitoring Manual and ensure compliance and consistent with study protocol and SOP.

Contact with CMC department regarding design of labeling, packaging and drug logistics.

Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and identifying issues, maintaining records.

Support contract review and negotiation with study sites.

Oversee study budget and verify site and vendor invoices related to related tasks.

Participate in regular cross-functional Data Quality Review and lead query resolution actions.

Conduct co-monitoring visits when needed, and review monitoring reports.

Ensure all vendors and sites invoices are reconciled and paid, and TMF are archived at the time of trial completion/closure.

QUALIFICATIONS:

At least bachelor’s degree in pharmacy, nursing, biochemistry, medicine or related major; Mater degree is preferred.

3-5 years industry experience with proven proficiency in clinical research. management for drug development.

Good understanding of ICH guidelines, GCP and regulatory requirements.

Proficiency in English (written and oral) and familiarity with standard IT office tools.

Excellent planning, organization and problem-solving skills.

Good communication and interpersonal skills.

Previous: Clinical Research Physician (Manager/Sr. Manager/AD)

Others

Clinical Research Physician (Manager/Sr. Manager/AD)

RESPONSIBILITIES:

The core responsibilities of a CRP are to implement clinical development plan for the assigned drug candidate, to provide medical and scientific expertise to project team, to lead clinical trial design, data review and interpretation, regulatory filing and scientific publication. The specific responsibilities include those listed below:

• Take the leadereship role in clinical trial the design, conduct and reportings.
• Provide overall medical oversight of BioNova’s clinical trials as assigned.
• Perform medical monitoring and clinical data review, including lab value, biomarkers, safety data, and coding report et al.
• Provide medical/clinical support and guidance to Clinical Operations for clinical study execution, including reviewing ICFs, CRFs, SAP, DMP, addressing IRB questions, reviewing protocol deviations, responding PI/site’s queries for subject eligibility and/or study conduct procedures
• Conduct medical and safety monitoring, review clinical lab values, AEs, coding dictionaries and data tables, listings and figures
• Write and review clinical protocol, IB, DSUR, CSR, and other clinical essential documents to support INDs/NDAs filing or other regulatory activities.
• Interact with inter-departmental and external consultants, KOLs, and regulatory agencies as appropriate.
• Organize and host advisory committee, steering committee, central review committee, IDMC, adjudication committee, etc when needed

QUALIFICATIONS:

• Medical Master is required. Medical Doctor is preferred.
• Profound knowledge and practice in hematology or oncology is preferred.
• At least three years of clinical development experience.
• Experience with medical and safety monitoring.
• Familiar with regulatory requirements; past interactions with health authority preferred.
• Fluent in written and verbal English

Previous: Clinical Project Manager/Sr. Clinical Project Manager

Others

Clinical Project Manager/Sr. Clinical Project Manager