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Clinical Project Manager

Function: Clinical operation

Base: Shanghai

?

Background

Terns China Biotechnology is a clinical-stage pharmaceutical company developing novel small molecule therapies for liver-related metabolic and oncological diseases.

?

Job Purpose

Clinical Project Manager will be accountable for the implementation, management and reporting of assigned clinical trials. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP) and in accordance with the International Conference of Harmonization (ICH) Guidelines. Will be a key member of the clinical project team working closely with the Medical Leader and other key function, will be accountable for all aspects of assigned study execution including where applicable, CRO selection, study plan design, execution, study start-up, CRO and vendor management and performance, study budget and timelines. Develops all study plans in collaboration with the CRO. Manages all aspects of clinical operational plan.

Major Accountabilities

?????? Develop clinical trial strategy and plan in collaboration with CRO and internal functions.

?????? Ensure successful completion of clinical studies that are on time, within budget and with high quality. Accountable for ensuring all needed aspects in clinical operations (drug, resources, contracts, budgets, trainings, meetings, documentations, etc.) are identified, planned and implemented in timely manner. Proactively identify potential issues/risks and mitigate, generate contingency plans and mitigation plans when necessary.

?????? Manage and monitor performance of all CROs and vendors to ensure successful completion of drug development program with regard to timelines, budget and quality.

?????? Manage the budget, contract requirements to ensure that trials/development program plans are on target.

?????? Review and contribute to key study documents including protocols, case report forms (CRFs) and Informed Consent templates.

?????? Review clinical data and metrics to identify trends.
??????

Background / Prerequisite

?????? Bachelor’s degree in Life Sciences, Pharmacy or Life Sciences. Advanced degree preferred.

?????? Experience working in managing clinical trials and operation

?????? Good working knowledge of GCP and ICH guidelines

?????? Title and compensation commensurate with qualifications and experience

?????? Proactive and organized with exceptional follow-up

?????? Anticipate/ identify problems and takes appropriate action to correct

?????? High degree of accuracy with attention to details

?????? Excellent team player


Document prepared by: Terns China Technology

Date of issue: 2018

Email:[email protected]


Clinical Research Physician

General

Job Title: Clinical research physician

Function: Clinical development

Base: Shanghai

Report to: Head of Clinical Research & Operation

Band: 4/5

?

Background

Terns China Biotechnology is a clinical-stage pharmaceutical company developing novel small molecule therapies for liver-related metabolic and oncological diseases.

?

Job Purpose

Clinical research physician’ s job is to drive the clinical development of compounds by applying clinical, scientific and drug development skills that meet the needs of the patients and other customers of our company.

Major Accountabilities

· Develop/review clinical trial protocol, IB, ICF, CSR, etc., medical materials

· Act as physician and monitor medical events during clinical trials operation phase

· Develop/review publications according to finished clinical trials

· Contribute medical input in pipeline/product strategy

· Give medical input in regulatory interactions
· Give medical input in cross-function interactions
??????

Background / Prerequisite

· Medical doctor with additional specialty training
· Above 3 years clinical practice
· Fluent English

· Documented experience in lab/clinical research experience

?

Measurement of success

·?Quality

·?Consist

·?Courage to facing difficulties

·?Ownership for what have done

·?New role/function knowledge learning

?

Document prepared by: Terns China Technology

Date of issue: 2018

Email:[email protected]

Function: Clinical operation

Base: Shanghai

?

Background

Terns China Biotechnology is a clinical-stage pharmaceutical company developing novel small molecule therapies for liver-related metabolic and oncological diseases.

?

Job Purpose

Clinical Project Manager will be accountable for the implementation, management and reporting of assigned clinical trials. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP) and in accordance with the International Conference of Harmonization (ICH) Guidelines. Will be a key member of the clinical project team working closely with the Medical Leader and other key function, will be accountable for all aspects of assigned study execution including where applicable, CRO selection, study plan design, execution, study start-up, CRO and vendor management and performance, study budget and timelines. Develops all study plans in collaboration with the CRO. Manages all aspects of clinical operational plan.

Major Accountabilities

?????? Develop clinical trial strategy and plan in collaboration with CRO and internal functions.

?????? Ensure successful completion of clinical studies that are on time, within budget and with high quality. Accountable for ensuring all needed aspects in clinical operations (drug, resources, contracts, budgets, trainings, meetings, documentations, etc.) are identified, planned and implemented in timely manner. Proactively identify potential issues/risks and mitigate, generate contingency plans and mitigation plans when necessary.

?????? Manage and monitor performance of all CROs and vendors to ensure successful completion of drug development program with regard to timelines, budget and quality.

?????? Manage the budget, contract requirements to ensure that trials/development program plans are on target.

?????? Review and contribute to key study documents including protocols, case report forms (CRFs) and Informed Consent templates.

?????? Review clinical data and metrics to identify trends.
??????

Background / Prerequisite

?????? Bachelor’s degree in Life Sciences, Pharmacy or Life Sciences. Advanced degree preferred.

?????? Experience working in managing clinical trials and operation

?????? Good working knowledge of GCP and ICH guidelines

?????? Title and compensation commensurate with qualifications and experience

?????? Proactive and organized with exceptional follow-up

?????? Anticipate/ identify problems and takes appropriate action to correct

?????? High degree of accuracy with attention to details

?????? Excellent team player


Document prepared by: Terns China Technology

Date of issue: 2018

Email:[email protected]

General

Job Title: Clinical research physician

Function: Clinical development

Base: Shanghai

Report to: Head of Clinical Research & Operation

Band: 4/5

?

Background

Terns China Biotechnology is a clinical-stage pharmaceutical company developing novel small molecule therapies for liver-related metabolic and oncological diseases.

?

Job Purpose

Clinical research physician’ s job is to drive the clinical development of compounds by applying clinical, scientific and drug development skills that meet the needs of the patients and other customers of our company.

Major Accountabilities

· Develop/review clinical trial protocol, IB, ICF, CSR, etc., medical materials

· Act as physician and monitor medical events during clinical trials operation phase

· Develop/review publications according to finished clinical trials

· Contribute medical input in pipeline/product strategy

· Give medical input in regulatory interactions
· Give medical input in cross-function interactions
??????

Background / Prerequisite

· Medical doctor with additional specialty training
· Above 3 years clinical practice
· Fluent English

· Documented experience in lab/clinical research experience

?

Measurement of success

·?Quality

·?Consist

·?Courage to facing difficulties

·?Ownership for what have done

·?New role/function knowledge learning

?

Document prepared by: Terns China Technology

Date of issue: 2018

Email:[email protected]

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