Novo Tech
Location
India | India
Job description
MinimumQualifications & Experience:
Graduateinaclinicalorlife sciencesrelatedfield.Atleastthreetosixyears'experience workinginaClinicalDataAssociate(orequivalent)roleinapharmaceuticalindustry or related role.
Responsibilities
Member of the project team reportingto the Biometrics Project Manager/Project Manageronprojects,the Associate ClinicalData Managerisresponsible for planning, conductingandmanaging ofallaspectsofdatamanagementforaclinicaltrialaccording tothe clientspecifications,protocol,projectplan, Data ManagementPlan, relevant GCDMP guidelines, regulatoryrequirements and SOPs.
Performthefollowingtasksundertheguidanceofa(senior)CDMand/orLine
Manager :
1. Determinationofprojectfeasibilityfromadatamanagementperspective.Understand the requirements of theproject agreement and scopeto ensurethat Novotech performstheseservicesasrequired.Iffull service,thencollaboratewithPMto ensure appropriatemitigation and contingencies areinitiated.
2. Participates in project team meetings as required.
3. Input into thepreparation of RFPs in liaison with BD and the clinical team.
4. Liaison with the project team and client for preparing and maintaining Data Management Plans.
5. Responsible for allaspects of data management including:
a. Designand review ofdatabasestructure, validation rules and consistencychecks. b. OperationofClinicalDataManagementsoftwarefordataentryofclinicaltrial
results.
c. All data cleaning/validation tasks
d. Development of allkeyData Management Documents
e. Liaisonwithclientcompanies/monitoring staff asappropriate,ensuring effective studycommunication with internal and external stakeholders
f. Liaison with external service providers on Data Management projects as appropriate.
g. Assisting thedevelopment of protocols as required.
6. Perform accurate studyfinancial projections andmaintain monthlyprojectfinancials.
7. Ensure changes in scopeareidentifiedand actioned accordingly
8. Activecontributiontocompanybusinessdevelopmentinitiatives,including involvementinthe implementationofdatamanagementplansforbusiness development in the companyingeneral.
9. Participation in industry conferences, professional association committee work etc) as ameans ofprofessional development as well as promotion of Novotech's imagein industry.
Independently performthefollowing tasks :
10. Perform comprehensive data management tasks including data review, query management, external data reconciliation.
11. Supervision andtrainingsupportforjuniorandcontractDataManagementstaffas required.
12. AdherencetocompanyQualityPolicyandproceduresasapplicabletocarryingout job responsibilities.
13. Identification of and participation in process improvement initiatives, as required.
14. Provideexpertassistanceandinput intointernalcross-functionalprojectsincluding clinicalresearchand regulatoryaffairs, as assigned.
15. ProjectmanagementofinternalIT-basedcompanyprojectsasassigned(e.g.intranet development, client database applications etc.).
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
Job tags
Salary
