(Associate Clinical Trial Operations Manager)
Job-holder’s Name: Manager’s Name:
Job Title*: Associate Clinical Trial Operations Manager (ACTOM) Manager’s Title:
Country: China Date:
The Associate CTOM is responsible for the overall or partial operational planning and activities for the implementation and conduct of studies (clinical trials, observational trials, compassionate use and registries) under supervision including data management activities in compliance with GCP’s, SOPs and standards within established timelines and budgets.
The Associate CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines under supervision to guarantee release of homogeneous high quality data, in close collaboration with others CSO department representatives (e.g. Medical Operations)
Duties and Responsibilities
Provide oversight of a study to ensure progress according to study timelines under supervision.
Associate CTOM contribute to or lead under supervisonclinical trial team (CTT) (including representatives from CSUs/affiliates/CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) and responsible for the operational aspects of the study.
Liaise with the feasibility manager to review and assess country feasibility.
Liaise with clinical purchasing to prepare the RFP (request for proposal), review vendors’ specifications and oversee vendor activities and deliverables (i.e., Central Lab, IVRS, data management, monitoring Meeting Planner).
Liaise with coding and TIM representatives when applicable.
Develop and manage the study budget under supervision
Develop study budget in collaboration with clinical purchasing department, local CSU (clinical study unit), UMO (Unit management office), review and validate country study budget.
During study conduct, review and track budget spending and perform monitoring on study budget and make complementary budget if needed.
Select, set up and manage vendors under supervision
Define needs, tasks and responsibilities of external vendors, review contracts, estimate costs of logistical aspects of the study and ensure tracking payments for operational aspects of the study are done in collaboration with the Clinical Purchasing department.
Closely work with vendors to set up central services on time and in high quality in conjunction with the CTT and provide oversight during study conduct to ensure study needs fullfiled.
Ensure proper study documentation
Develop following study documents as the author under supercision: Monitoring Plan, Study Communication Plan, study-specific procedures and study operational material (e.g. study newsletters, memo, etc) as needed;
Co-develop documents with vendors (specifications of central services, scope of work, operational manual, etc) in conjunction with the CTT.
Review CTT-developed documents including ES, protocol, amendments, and WSI (operational sections) , Data Management Plan, the Data Validation Plan, the Case Report Forms (including testing) and completion guidelines, data transfer plan, the Data Review & Surveillance Plan, recruitment and retention plan, committee chaters and/or other operational documents as requested to provide operational input (including on-time and high quality).
Ensure that clinical standards are followed for the study.
Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant E-rooms and databases as required.
Ensure proper collection and validation of data and documentation on a timely manner
Assure proper overview and communicate to teams of monitoring activities, data flow, data validation and when applicable, coordinates the centralized review of procedures in collaboration with data manager, local CSU and relevant functions
Investigational Product (IP) Management under supervision
Collaborate with the CSOM (Clinical Supply Operational Manager) to validate study IP needs, specifications, packaging, shipment (including resupply) and reconciliation process.
Collect, synthesize and report study information
Maintain and provide information for monthly study highlights (including enrollment curves and timelines) on a timely manner
Preparation and oversight of study audits/inspections both internal and external under supervision
Ensure preparation and proper responses to audit/inspection reports & consolidation of findings and communicate important observations to CTT and/or DPE and Team Leader.
Develop and implement immediate action plan at global CSU/sites level if needed.
Support the preparation for pre-approval inspections (PAI)
Upon request, prepare and assist in PAI preparation plan with the PAI project team.
Utilize designated tools developed to oversee quality (e.g. Polaris BO reports, etc) for an Inspection-readiness approach and to prepare for CSU CTTs & DRS meetings to optimize monitoring efficiency & quality.
Knowledge and Skill Requirements
- Project Management skills
- Strong interpersonal and communication skills (verbal and written)
- Strong English skills (verbal and written if English is the second language)
- Ability to handle multiple task and to prioritize, strong organizational and presentation skills
- Leadership skills
- Decision-making and problem-solving skills
- Ability to work efficiently & effectively provide status reports
- Ability to anticipate and timely escalate issues and to define appropriate action plans
- Good cross-functional collaboration to foster team spirit and team motivation (team work)
- Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs
- Experience in managing and capable to lead international meetings (Clinical Trial Team, expert meeting, etc) with coaching
- Ability to work in an international environment with internal and/or external partners (CROs etc)
- Ability to adapt and be flexible to change and managing internal and external impediments
- Knowledge or ability to rapidly gain knowledge with programming/query languages
- Understanding of data base concepts preferred
Bachelor's degree (advanced degree preferred) plus at least 5 years of experience in pharmaceutical industry or clinical-related discipline with clinical research project management experience. To be customized upon country specificities
Job Holder’s Signature/Date Manager’s Signature/Date
*(Job titles will be subject to harmonization)
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