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CTSS Officer

Shanghai, Shanghai Municipality

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Req ID 57412 Title CTSS Officer City 上海 State / Province 上海市 Country 中国 Region 亚洲/太平洋地区


A. Leadership:
(1) Provides line management support for Country CTSS Representatives including PM process, succession planning, merit process. In collaboration with Clinical Development Director (CDD).
- Set objectives (aligned with region).
- Ensure Performance Management (PM) plans are created for direct reports.
- Review progress of performance plans through PM.
- Ensure coaching and supervision of the CTSS staff.
- Recognize and reward direct reports proactively.
- Monitor work/ life balance.
(2) Responsible for staff recruitment, development and retention- according to affiliate and Clinical Development Organization (CDO)objectives, leverage diversity of our people and collaborators( experience, ethnicity, thought, gender, geography, etc. ) to thrive in a networked environment. In collaboration with CDD:
- Ensure training program is in place for direct reports.
- Ensure development plans are created for direct reports.
- Contribute to the Clinical Operations succession planning.
(3) Conflict resolution, issue management and appropriate escalation.

B. Administration and Clinical Operations Support
(1) Support the maintenance of study Trial Master Files and any other internal reporting systems as applicable(2) Assist in the preparation of submission files.
(3) Prepare documentation for close out and archive in-house files.
(4) Arrange for destruction of ‘non-archive’ materials post study.
(5) Assist Clinical Development Director, Sr. Clinical Development Manager, Clinical Development Officer as required to run relevant reports.
(6) Responsible for the updating of clinical research related systems, e.g. IMPACT, PCE.
(7) Oversight the logistic support for site safety mailing ethical committee submission
(8) Provide operational expertise and oversight the operational support in local IIT, include preparing IIT study contract and/or IP based on internal approved IIT proposal, tracking IIT enrollment progress, coordinating distribution to site and processing site payment, if applicable.
(9) Oversight the local site study equipment leasing process
(10) If applicable, supporting of CDD, CDM,CDO in administrative tasks, depending on local situation eg. Coordination and set-up of meetings, agenda, minutes, travel arrangements, couriering, post duties etc.

C. IP/non-OP Operation Support (for affiliates with TPO managed warehouse)
(1) Source of IP(commercial material) and non-IP supplies
(2) Support management of IP and non-IP supplied, ensure adequate storage conditions and accountability, report deviations and follow up on resolution
(3) Manage inventory and re-supply, as applicable
(4) Management of import/export activities related to IP/non-IP supplies.
(5)Coordinate shipment/return/destruction.
(6) Ensure relabeling is performed in compliance with internal/external regulations.
(7) Provide operational expertise to IP distribution management training for CRAs
(8) Provide support before and during audits/inspections.
(9) Cooperate with line manager and MQR to ensure appropriate audit/ inspection responses are provided and implement corrective actions.

Basic Qualifications

- Education in Business administration of health care related fields
- At least 2years Clinical Research experience
- Strong knowledge of regulations, legislations and guidelines applicable for the conduct of clinical trials
- Experience in coaching and developing technical personnel
- Strong interpersonal skills, including capability to engage in professional relationship building and networking.
- Demonstrated decision-making ability
- Strong organizational, analytical and problem-solving skill
- Excellent written and verbal communication, and presentation skills
- Strong leadership skills
- Ability to work according to strict deadlines, prioritize and manage multiple customers
- Strong negotiation and arbitrations skill
- Excellent customer relationship skills
- Fluency in both verbal and written English

To submit resume, visit and apply to Req ID 57412.

Lilly is an EEO/Affirmative Action Employer and 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.

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