The position is responsible for hiring, managing, developing and being accountable for the Early Stage (ES) Data Services (DS); and Support DS teams in managing operations, client key performance indicators (KPIs); serve as Specialists in the assigned function/department; and for meeting assigned Quality targets including but not limited to quality, Compliance of client Service Level agreements (SLA), impart trainings, coach&, guide teams DS practices.
Serve as subject matter expert (SME) in the area of early stage services.
Responsible to oversee ES, DS day operation in CDM, CDMP, Biostatistics, Bio statistical Programming, Medical Writing services, data standard group.
Serve as single point of contact (POC)-Interact with other departments like Data Service Project Management (DSPM), DS & ES to ensure high level Quality execution of projects.
Participate in project kick off meet and support functional leads to create and manage project plan and support the function till project closure.
Responsible for proactively identify the risk stages in operation asses the compliance to ICH-GCP, SOPs & client SLAs.
Support regional Inspection readiness activities.
Accountable for delivery of regional quality improvements & Client KPI& SLAs in ES data services.
Required to participate in client, internal or agency audits and inspections.
Ensure that all project related documents are as per client and internal inVentiv Health process and placed in appropriate folders/files. ensure that eTMF is up to date
Meet Operation & leadership at scheduled intervals to discuss project progress, quality issues, CAPAs, SQIs, audits/ inspections.
Ensure smooth communication with respective stakeholders within global data services and Early stage
Responsible to Identify and quantify resource requirements and projections for ES-DS.
Interview, hire, onboard and train new staff as appropriate. And Train the trainer and oversee all related activities
Provide inputs to Business Development related activities as required.
Represent client related meetings and professional meetings.
May write training materials and/or perform training for ES-DS staff
May participate in the development of department standard operating procedures and guidelines and evaluating staffing need.
Salary:INR 12,00,000 – 22,00,000 P.A
Industry:Pharma / Biotech / Clinical Research
Functional Area: Other
Data Services Early stage Clinical Data Management Biostatistician Statistical Programming Clnical Data Management programming Project Management Client interaction Team Management
Desired Candidate Profile:
Eight to ten (8-10) years of progressively responsible early stage clinical research work.
Minimum 4-5 years of experience as subject matter expert in Early stage (BA-BE & PK-PD) studies.
Minimum of 4 to 5 years of experience ES project management.
Three (3) years of direct client interaction experience.
At least four (4) years of direct ES Data Services(cross functional) management experience
Ability to deal effectively with internal and external customers
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Ability to travel as necessary.
Have solid understanding of ICH-GCP & ES regulatory
Hiring for reputed pharmaceutical MNC for Hyderabad Location
Address:C-8, Malti Housing Society, Senapati Bapat RoadPune 411016PUNE,Maharashtra,India 411016
Reference Id:SME 17.12.2016