Job Description

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India. The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data. We are currently looking for an enthusiastic and talented Project Specialist. This role can be home-based in Pune, India and will require occasional days in the office. Core Accountabilities The Project Specialist (PS) provides superior project task delivery and supports the Project Management and Clinical Operations team with specific project planning, financial management, tracking, and organizational tasks and delivers all tasks accurately and in compliance. Project Specialist accountabilities and responsibilities will vary based on the assigned project scope (i.e. limited service versus full service projects). Principal Responsibilities Project Manager Support Provides project management support to theProject Manager throughout the project end to end process Provides support to the project by ensuring that all tasks described herein are completed, coordinated within the team and communicates to the Project Manager at all times Collates and distribution project information and documentation Escalates any project matters appropriately to PM and fulfils actions from escalation Provides effective cover for PM on specific tasks in absence or via PM delegation. Access Management Sets up study information or documentation systems/repositories (eTrial Master File (eTMF), network/study email repository, portals etc), and monitors correct use by project teams Supports PM system setup and performs PM access management / access review procedures (eTrial Master File (eTMF), network/study email repository, portals, clinical database, etc), and fulfils documentation requirements for reviews performed Performs project archive tasks Project Financial Management Compliant with time recording structure for project/s, and supports distribution of financial/budgetary materials to study team Supports month-end financial reporting into reporting systems Supports verification of invoices and pass through costs with project teams Supports PM checks and corrections on project financial results (e.g. minor deviations, time reporting issues and corrections) Project Tracking Sets up and enters project tracking information into PM tools (KPIs, metrics, status reporting, RAID, etc). Closes project-instance of system at closure of services. Has overview understanding of project plan tools, and supports follows up and tracking of project actions and timelines KPI and metrics data collation and reporting Creates and maintains accurate and timely study team lists Attends study meetings, as required Project Documentation Actions study documentation tasks as required, including submissions to eTMF, coordination of non-electronic PM TMF content, and Document QC rework issues Maintain study information/milestones, as assigned (e.g. in eTMF) Reviews and actions eTMF Metrics; monitors project inspection-readiness Set up and coordination of TMF reviews to ensure tasks will be completed by due date Contacts external contributors regarding TMF reviews and completeness confirmations Performs PM TMF review tasks Administers TOP Familiarization Record. Other Project Specialist Undertake all tasks assigned to role within Aixial Group SOPs, or as delegated by PM Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team member Participate in Initiatives and SOP review to enhance operational processes, as requested Participate in creation of project training materials, as applicable Mentoring of junior staff as required Additional The above job description in no way states or implies these duties are the only duties performed by this employee.The incumbent is expected to perform other related duties necessary for the effective operation of the department and company. The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company. Desirable Work Experience, Qualifications And Knowledge University/college degree Experience within human clinical trials industry Work experience in corporate environment Attributes Planning and Organisational Skills: Fulfils study duties consistently and in timely manner across multiple concurrent clients/study types Fulfils all responsibilities in methodical manner at all times Ability to monitor own work progress, and proactively assess/flag when tasks are not progressing as planned Manages conflicting priorities of timelines and deliveries when things change, to get the best for their project Provides focus and clarity to work out ambiguous project issues/tasks with team - do not shy away from complicated matters Resolves project conflict to permanent solution Acts calm under pressure; resilience to conflict/setbacks Good organizations skills Communication And Teamwork Establishes productive and positive relationships within study team and extended team Articulate, positive, concise and accurate communication style Takes initiative with problem solving; facilitates team to resolution throughout project; implements clear shared action plan Considers impact of all risks and decisions on project/team; listens to all opinions Reaches out to leverage other expertise where needed Leadership Has drive and ambition to develop into Project Manager role Takes ownership of all responsibilities and honours commitments Handles multiple projects with positive attitude Works effectively with all individuals and teams Technical Ability to demonstrate good computer skills Expertise using Microsoft Word, Excel, PowerPoint, MS Project, SharePoint and/or ability to learn new systems quickly For more information on Aixial Group Recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - https://www.aixialgroup.com/join-us/ Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Aixial Group HR or Talent Acquisition Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.

foundit