Sanofi Group Clinical Trial Operations Manager in Bridgewater, New Jersey

Clinical Trial Operations Manager


Sanofi, an integratedglobal healthcare leader, discovers, develops and distributes therapeuticsolutions focused on patients’ needs. Sanofi has core strengths in the field ofhealthcare with seven growth platforms: diabetes solutions, human vaccines, innovativedrugs, consumer healthcare, emerging markets, animal health and the newGenzyme.

Job Title: Clinical Trial Operations Manager

Job Description:

The CTOM is responsible for the overall operational planning and activities forthe implementation and conduct of studies (clinical trials, observationalstudies, compassionate use and registries) including data management activitiesin compliance with GCP’s, SOPs and standards within established timelines andbudgets.

The CTOM is involved in the scientific conduct of the study and acts as theleader of operational disciplines to guarantee release of homogeneous highquality data, in close collaboration with other CSO department representatives(e.g. Medical Operations)

May be required to take-on the Dedicated Project Expert (DPE) role depending onCTOM’s level of experience, relevant skill-set and business needs.

Provide oversight of a study to ensure progress according to study timelines.

End Results Expected:

Lead the clinical trial team (CTT) (including representatives fromCSUs/affiliates/CROs, GPE, Medical Operation, Biostatistics, Clinical SuppliesPlatform, Regulatory, Pharmacokinetics and other relevant departments) for theoperational aspects of the study. Liaise with the feasibility manager to reviewand assess country feasibility. Liaise with clinical purchasing to prepare theRFP (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 whenapplicable.

Ensure proper documentation/availability

End Results Expected:

Contribute to the extended synopsis, protocol, amendments, and WSI (operationalsections) development and review to ensure operational feasibility; Definitionof the Case Report Form content and testing of the end product.

Develop study-specific procedures and write the Monitoring Plan, the DataManagement Plan, the Data Validation Plan, the Case Report Forms (includingtesting) and completion guidelines, the Data Review & Surveillance Planand/or other operational documents in conjunction with the CTT. Review otherCTT and vendor-developed or co-developed documents (e.g., specifications, scopeof work, operational manuals, communication plans, retention and recruitmentplans, data transfer plans, etc.) as requested to provide operational input(including on-time and high quality).

Ensure appropriate testing/UAT are performed as required (e.g. eCRF screens,database structure, data loading, etc)

Ensure that clinical and data management standards are followed for the study.

Ensure proper collection and validation of data and documentation on a timelymanner

Assure proper overview and communicate to teams (including on-time and highquality) of monitoring activities, data flow, data validation and whenapplicable, coordinates the centralized review of procedures.

Perform patient data validation homogeneously and fulfilling required qualitystandard.

Ensure study documentation is properly maintained and archived in the TrialMaster File (TMF) and relevant E-rooms and databases as required.

Organize study specific meetings (CTT excluded)

Coordinate and support field-monitoring activities through regular meetings:teleconferences and/or visits to CSU’s, training of monitoring teams,investigator meetings. CRO management if applicable.

Prepare and lead data review meeting, organize and contribute to medical reviewmeetings.

Collect, synthesize and report study information.

End Results Expected:

Maintain and provide information for monthly study highlights (includingenrollment curves and timelines) on a timely manner

Investigational Product (IP) Management.

End Results Expected:

Collaborate with the CSP to validate study IP needs, specifications, packaging,shipment (including resupply) and reconciliation process.

Participate in the development/follow-up of the study budget and selection andmanagement of vendors.

End Results Expected:

Define needs, tasks and responsibilities of external vendors, review contracts,estimate costs of logistical aspects of the study and ensure tracking paymentsfor operational aspects of the study are done, in collaboration with theClinical Purchasing department

Preparation and oversight of study audits/inspections both internal andexternal

End Results Expected:

Ensure preparation and proper responses to audit/inspection reports & consolidationof findings and communicate important observations to CTT and/or DPE and TeamLeader.

Develop and implement immediate action plan at global CSU/sites level if needed

Provide oversight and preparation for FDA pre-approval inspections (PAI)

End Results Expected:

Upon request, prepare and assist in PAI preparation plan with the PAI projectteam.

Utilize designated tools developed to oversee quality (e.g. Polaris BO reports,etc) for an Inspection-readiness approach and to prepare for CSU CTTs & DRSmeetings to optimize monitoring efficiency & quality

Mentors/trains new comers

End Results Expected:

Participate, as a delegate to TL, to the training of new CTOMs on therapeuticarea and general responsibilities within their function

Dedicated Project Expert (DPE) role:

The Dedicated Project Expert (DPE) is a role performed by a senior ClinicalTrial Manager (CTM), senior Study Data Manager (SDM) or senior Clinical TrialOperations Manager (CTOM) in addition to his/her direct study responsibilities;direct study responsibilities may be adjusted depending on the coordinationactivities workload of the designated clinical program.

The DPE is accountable for operational oversight of the clinical programconducted within Trial Operations. He/she coordinates with CTM(s), SDM(s) andCTOM(s) working on the designated program to ensure operational consistency, toidentify possible synergies, and to ensure that the team works closely togetherto meet the program goals on time and with good quality.

The DPE assists the CSO CSP Project Leader (PL) in developing/ following theexecution of the program operational statement. The DPE is the primary point ofcontact for PL within TO and will represent CTMs/SDMs/CTOMs working on programas the designated CSO CSP Project Team Member. He/she is the primaryresponsible person for escalation of program issues/information within TrialOperations and will ensure that PL and TL are being provided with regularreporting on the program progress.

The DPE provides input to help TL ensure alignment according to risk adjustmentand study milestones.



Bachelor'sdegree (advanced degree preferred) plus at least 7 years of experience inpharmaceutical industry or clinical-related discipline including at least 5years clinical research experience, including

2years of trial operations management.

Capableof interacting effectively with scientists and managers within and outside CSOSCP; serve as internal consultant on assigned area and liaise with externalorganizations on projects.

-Strong interpersonal and communication skills (verbal and written)

-Ability to handle multiple task and to prioritize, strong organizational andpresentation skills

-Leadership skills

-Project Management skills

- Decision-makingand problem-solving skills

-Ability to work autonomously and to efficiently & effectively providestatus reports

-Ability to anticipate and timely escalate issues and to define appropriateaction plans

- Goodcross-functional team leader who fosters team spirit and team motivation (teamwork)

-Knowledge and qualification with international standards (e.g. GCP, CDISC,etc.), company tools (including data management systems), processes and SOPs

-Experience in managing and leading international meetings (Clinical Trial Team,expert meeting, etc)

-Ability to work in an international environment with internal and/or externalpartners (CROs etc)

-Strong English skills (verbal and written if English is the second language)

-Ability to adapt and be flexible to change and managing internal and externalimpediments

-Understanding of data base concepts preferred

-Knowledge or ability to rapidly gain knowledge with programming/query languages

-Knowledge of industry data management standards andpractices


Job: Clinical Development

Primary Location: United States-New Jersey-Bridgewater

Job Posting: Sep 30, 2016, 8:04:33 AM

Job Type: Regular

Employee Status: Regular