Project Manager - Clinical @ Intelliest Technology

Job Description

Job Details Job Location India - Puppalguda Villege, Gandipet Mandal, Description Job Purpose The project manager (Clinical) will assist in the planning and execution of clinical development projects from Phase 1 through commercialization with a specialization of clinical operations (Phase 1-3) Pharmacovigilance while adhering to schedule, scope, and budget requirements. Duties And Responsibilities The successful candidate will work alongside the clinical operations team helping to translate clinical strategy into detailed project plans. Creating project charts and considering key strategic assumptions from each of the clinical sites and cross-functional dependencies. Create a monitoring chart for each clinical trial (all the projects) and update those charts on regular basis as agreed with the management team. Chart updates will also be shared with the PMO and Head of clinical regularly. Analyze, plan, and track project activities on regular basis; proactively identify. and resolve operational challenges from different clinical sites and minimize delays that may impact cross-functional teams. Alliance management of clinical sites. Track critical path tasks and identify project risks during various stages of clinical operations/development. Communication of risks to relevant stakeholders. Work with external CRO or vendor(s) to track project timelines and monitor KPIs. Coordinate functional project teams and take full accountability of deliverables, balancing quality and timeliness. Ensure fluid project communication and report project status to project and program leadership. Implement best practices across project teams e.g., resource capacity planning, project risk management, team performance, timeline development, portfolio management. Work with functional leaders to ensure positive team spirit and high functioning team. Prepare monthly progress reports and ad hoc reports as required. Participates in development of Project Management tools, templates, and processes. Ability to work outside the typical work hours to accommodate the clinical sites schedule. Track spending verses budget projections and identify resource needs. Additional tasks and projects as requested. Qualifications Bachelors degree in a science discipline or related field is required. M.S. degree desirable. Minimum 5-8 years of pharmaceutical industry experience, with at least 3-5 years managing clinical projects either directly or through a CRO. Experience in pharmaceutical drug discovery and development, clinical research/development, or product launch programs. knowledge of Good Clinical Practice/ICH guidelines and applicable regulatory and ethical requirements. Possesses knowledge of all phases of clinical studies as part of drug development cycle. Knowledgeable in PM processes and can competently use and employ essential project management tools and methodologies to facilitate project team activities, manage risks and ensure team execution PMP certification preferred. Advanced working knowledge of MS Project, OnePager Pro, Excel, OneNote, and PowerPoint. High level of personal integrity and strong conflict resolution and consensus building skills. Ability to work effectively with cross-functional teams. Ability to travel to the clinical sites based on the requirement. Working conditions Incumbent will primarily work Monday Friday during normal business hours in an office environment. Travel up to 10% may be required. Physical Requirements This is a largely sedentary role.

Employement Category:

Employement Type: Full time
Industry: Medical / Healthcare
Role Category: Medical / Healthcare
Functional Area: Not Applicable
Role/Responsibilies: Project Manager - Clinical

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Keyskills:   Clinical Operations Pharmacovigilance Project Management Clinical Research Drug Development Good Clinical Practice Regulatory Requirements MS Project Excel PowerPoint Project Risk Management