Job Description:

a) Plans and executes study level project management activities for assigned studies including study level timelines, risk assessment, mitigation plans, and other aspects of study level project management (e.g. budget, metrics).
b) Develop and get alignment with internal senior management team and cross-function team and external partners on milestone dates and tracks overall timeline to ensure delivery throughout the whole study.
c) Closely monitor the status of ongoing projects. Identifies potential issues, risks in a timely manner that may affect the critical path of the clinical study and project milestones.  including vendor selection, site selection, study start up, patient enrollment, date base lock, site closure, study inspection. etc.
d) Ensures quality compliance at the study level to achieve study /country /site level compliance, as appropriate. Ensure appropriate regulatory requirement, GCP/SOP compliance.
e) Work as the key point of contact between internal and external clinical research partner at the study level, maintain relationships with different cooperation partners. 
f) Oversight the performance of 3rd party venders, including but not limited to CRO/SMO/central lab/central imaging/PRO ects throughout whole study.
g) Dynamically reviews study team resource, provides timely actions in order to keep reliable staffing resource strategy.
h) Develops/provides/supports study related training to study team, as appropriate.
i) Obtains clinical study cost forecasts. Establishes and monitors the study budget.
j) Maintains and archives at study level documentation.k)Other appropriate responsibilities assigned by line manager.

Qualifications:

1) Bachelor's degree in a scientific or health care related field, e.g clinical medicine, nursing, biological Sciences etc.
2) Comprehensive understanding of Good Clinical Practices, Good Documentation Practices, FDA/NMPA regulations.
3) Excellent interpersonal skills and demonstrated business acumen with an ability to interface successfully with internal and external cross-functional teams and individuals.
4) Excellent verbal and written communication skills. Good at oral and writing English.
5) Excellent office computer skills, including experience with clinical databases.
6) Effective cross-functional team player with ability to work in a team environment.
7) Demonstrated leadership skills and strong result driving.
8) Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities; with a high tolerance for ambiguity.
9) Experienced in serving on product development teams and understands the product development lifecycle.

Job Description:

a) Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
b) If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
c) Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
d) Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
e) Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
f) Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
g) Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
h) Build awareness of features and opportunities of study to site.
i) Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications:

1) Bachelor's degree in a health care or other scientific discipline or educational equivalent and 3 years related working experience; or equivalent combination of education, training and experience.
2) Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
3) Strong therapeutic and protocol knowledge as provided in company training.
4) Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer.
5) Strong written and verbal communication skills including good command of English language.
6) Strong organizational and problem-solving skills.
7) Effective time management skills.
8) Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Job Description.

1、According to the company's overall development strategy and R & D strategy, responsible for the progress tracking and coordination of the whole process from formulation development to production transfer, solving technical problems encountered in the process, organizing the forces of technical research to be responsible for the completion quality of the project.
2, Grasp the development trend and dynamics of formulation technology research, participate in project establishment, formulate formulation R&D project plan, and supervise the implementation of the plan.
3, Responsible for drug formulation prescription screening, process research and optimization, and realize the transformation to pilotscale experiment and large production.
4、Responsible for the overall coordination arrangement of the work related to the domestic registration of drugs, the authenticity, completeness and accuracy check and audit of the declaration materials, diagrams, original records, etc..
5、Participate in the corresponding project introduction assessment and CRO cooperation, responsible for the equipment required for the preparation project test, material procurement review and approval.

Job requirements.

1、Master's degree or above in pharmacy related majors; more than 3 years of experience in management of formulation R&D team.
2, More than 8 years of experience in formulation R&D, experience in product registration and drug declaration projects, experience in innovative drugs is preferable.
3、Familiar with formulation R&D management, with rich experience in dosage form improvement, technological scale up, analytical R&D. Experience in tablet R&D in large domestic and foreign pharmaceutical companies is preferred.
4、Familiar with the relevant policies and regulations of drug development and registration, national new drug approval technical requirements and review trends, with multiple projects successfully developed to complete the declaration of production experience is preferred.
5、Good at organization and coordination, communication, and have excellent listening, speaking, reading and writing skills in Chinese and English.