The Job logo

What

Where

Sr Project Support Coord

ApplyJoin for More Updates

You must Sign In before continuing to the company website to apply.

Smart SummaryPowered by Roshi
Coordinate, oversee, and complete functions on assigned trial activities. Ensure tasks are performed within budget and to high quality standard. Support study documentation maintenance and global support. Provide system support and perform administrative tasks on assigned trials. Support scheduling and organization of meetings. Drive ISF template compilation. Attend project meetings and support study set-up.

Job description 

Job Description

 

  • Coordinates, oversees and completes functions on assigned trial activities detailed on the task matrix.
  • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. Follows up for resolution of findings and escalates whenever necessary.
  • Ensures allocated tasks are performed on time, within budget and to a high quality standard. Escalates in cases of variances (overburn/underburn) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSC’s free capacity (in case involved in a Lead role).
  • Supports the maintenance and oversight of study specific documentation and global support with specific systems, tools and trackers including, but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system.
  • Provides system (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents, maintaining audit readiness and communicating the non-compliance to the study team and suggesting resolution.
  • Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG's/Client eTMF as required, performing CRG's/Client eTMF reviews and coordinating and proposing issue resolution, performing mass mailings and communications as needed, providing documents and reports to internal team members.
  • Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes and follow up for closure of action items, if required.
  • Exports and reconciles study metrics reports, and if required analyzes and identifies issues (if involved in a Lead role.
  • Maintains and regularly checks for correctness of vendor trackers.
  • Drives and coordinates the compilation of Investigator Site File (ISF) template, pharmacy binder with instruction from the Clinical Team Manager.
  • Attends Kick off and Project Launch meetings and takes notes when required, supports initial study set-up.

     

Education and Experience:

High  /  Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).

Set alert for similar jobsSr Project Support Coord role in Mumbai, India
Thermo Fisher Scientific Logo

Company

Thermo Fisher Scientific

Job Posted

6 months ago

Job Type

Full-time

WorkMode

On-site

Experience Level

3-7 Years

Category

Software Engineering

Locations

Mumbai, Maharashtra, India

Qualification

Bachelor or Master

Applicants

Be an early applicant

Related Jobs

Thermo Fisher Scientific Logo

Technical Support Manager- South and East IC-SP

Thermo Fisher Scientific

Mumbai, Maharashtra, India

Posted: 10 months ago

Job Details for Technical support! Support Thermo Fisher customers through enhanced technical service, training, and Troubleshooting specialized – Analytical equipment like Ion chromatography and have excellent technical proficiency in the IC-SP product line.Undertake product installation on client premises and demonstrate the features related to 21 CFR, compliance. In the CDS software. Provide training and technical advice on instrument use, both in person and through phone by sharing notes Dos and Don’ts for optimum performance of the system. Investigate difficulties and address faults arising from the operation or utilization. Resolve problems suggest solutions or arrange for repairs to be made.Provide an important link between customers and Sales and Marketing. Provides a communication link between the customer and the company to help ensure that effective service is provided to the customer. The candidate should have a good understanding of Windows-based tools for Analysis of data. Carry out plans if the repeated problem on the same system or FSE is unable to diagnose over remote support at a particular location and perform customer visits with accurate coordination among FSE, RSH, ZSM as well and the customer. Make recommendations about spare parts requirements and assist with monitoring equipment. Achieve the Depot repair efficiency, Remote resolution and PM checklist of FSE, accurate guide to FSE over remote support, and service revenue targets by prompting maintenance contracts, PM kits, instrument hardware upgrades, software upgrades, and calibration of the systems, etc. The role is required whenever traveling within the territory and may call for travel outside the territory if an emergency arises. The candidate must be self-motivated, hardworking have a positive approach, perform as an extraordinary teammate, and be able to handle confidential and proprietary information with sensitivity. Reliable, detail-conscious, and results/tasks orientated. Knowledge, Skills, abilities: - Bachelor of Technology or M.Sc (Instrumentation/ Electronics) Proficient written and verbal communication Interpersonal skills suitable for a people-oriented job, requiring interactions with many people both inside and outside the organization Ability to prioritize technical service support and Remote support resolution, produce clear and concise documentation Self-motivated and proactive in technical and support approach. Closely work with customers, FSE, RSH, and ZSM in understanding customer pain areas and be a consultant between the organization and the customer thereby helping the customer and organization to achieve our regional commercial goals. Build good rapport with customers and educate the customer regarding maintenance contract entitlements and procurement of PM kits annually to improve system availability.  

Thermo Fisher Scientific Logo

Sr Medical Writer - Early Development

Thermo Fisher Scientific

Mumbai, Maharashtra, India

Posted: a year ago

A day in the Life: Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies. Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge. Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes. May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications. Represents the department at project launch meetings, review meetings, and project team meetings.   Keys to Success: Education Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred   Experience Previous regulatory medical writing experience required (comparable to 5+ years). Experience working in the pharmaceutical/CRO industry preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous   Knowledge, Skills, Abilities Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills Strong project management skills Excellent interpersonal skills including problem solving Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Thermo Fisher Scientific Logo

Project Manager III

Thermo Fisher Scientific

Pune, Maharashtra, India

Posted: a year ago

Role Description :  Responsible for handling Projects to ensure smooth delivery and I&C completion till the handover of the equipment as per the scope of the Order. Collaborate with internal & external partners and handle timely deliveries and excellent quality.  Deliver Project important metrics and ensure customer delight.   Task & Responsibilities   This position requires delivering Planning, Supervising and smooths communication with various partners including customers. Developing project scopes and objectives, involving all relevant partners, and ensuring technical feasibility. Ensure resource availability and allocation and perform risk management to minimize the project risk. Develop a detailed project plan to supervise progress and report and call out to management as needed Use appropriate verification techniques to manage changes in project scope, schedule, and costs Reviewing the material requirement with all partners for setting up and launching the facility and tracking till receipt and implementation. This position is leading in managing raw materials and personnel. Oversight of inventory, purchasing, and supplies is central to the job. This position will play a key role in budgeting, controlling costs, and keeping the organization on track financially. Understand business forecasts, sales reports, and financial statements and find ways to improve results. Use methods such as cost-benefit analysis to improve efficiency. Setting goals and objectives and establishing policies for various departments in the organization aligned to Project requirements. Managing the budget. This may include finding quality equipment at a cheaper price or finding ways to lower production expenses by optimizing the production process. Manage inter-departmental communication to ensure that each is working in harmony toward production goals, while also meeting quality standards Manage Customer Service Issues directly related to product or equipment quality. Cascade the Goal Tree and Deliver the AOP. Generate weekly Reports on Revenue, Production Status, FPY’s and Risk Mitigation plans. Overall responsibility for the unit's Quality, Environmental, Health and Safety aspects. Ensure the relevant Quality management systems are deployed and handled. Responsible for OTD’s & OTR’s Supervise and report monthly all major Operational parameter like Inventory, CAS-OF, HeadCount, Overtime, LTI, Training hours, Savings, Efficiency, Past Dues, FPY’s, and Linearity of revenue. Performance Measurements On-Time Deliveries:  "As forecasted" and "as delivered" Margin / Cash Conserved:  Difference between "As Budgeted" and "Spent". Objectives, Targets, and Performance Measurements are defined on a yearly basis. Authority Approval of Procurement initiation Approval of suppliers' invoices Qualification BE in Instrumentation / Electronics / Electrical / Mechanical PMP / Prince2 certification is helpful Skills, Knowledge, and Experience Communication and negotiation skills Project management skills Experience in project management tools latest to the market requirement. Commercial awareness proficiencies Leadership skills to drive the project resources Knowledge in scaling up a manufacturing facility Strong in people management, planning, forecasting, and budgeting skills Communication: Proficient in Written and Spoken English, Good Presentation skills

Thermo Fisher Scientific Logo

Sr Systems Developer

Thermo Fisher Scientific

Bangalore Urban, Karnataka, India

Posted: a year ago

Job Description   Essential Functions: Designs and develops components and services according to specifications within a team environment. Performs systems analysis and prepares detailed system documentation including requirements, specifications, test plans and user manuals.  Ensures knowledge base is organized and maintained per departmental standards; provides cross-training, coaching, and mentoring as needed; assists in the management of work assignments across the team; provides performance feedback on support team. Effectively manages ticket queues ensuring adherence to Service Level Agreement (SLA) and departmental guidelines, identifies and escalates critical tickets, monitors queues for compliance. Works with business partners and peers to analyze and resolve support requests. Serves as lead for planned and unplanned outages, oversees activities including staff assignments, coordination, and communication; mentors and ensures team is positioned to support outages.  Provide guidance to junior staff in executing systems development responsibilities Assists DBA with database design. Coordinates with Operations staff on deployment of applications. Collaborates with other IT groups to include support and deployment of product. Ensures all activities are performed with quality and compliance. Must be able to multitask and pay close attention to detail Client focused approach with strong interpersonal skills   Qualifications Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years’) or equivalent combination of education, training, & experience.   Knowledge, Skills and Abilities: Excellent knowledge and demonstrated use of Talend ETL, APIs, Web Services and relate technologies Strong ETL knowledge in real time jobs, batch jobs, scheduling and web services Strong knowledge of ETL concepts and related technologies/protocols (SOAP, SOA, XML, etc.) Excellent knowledge of basic relational database platforms (Oracle, SQL Server) and languages (PL/SQL, SQL) Experience integrating with Oracle Cloud ERP/HCM highly preferred Strong logic, analysis, and problem-solving skills   Must be able to multitask and pay close attention to detail Client focused approach with strong interpersonal skills   Must be willing to work IST 3rd Shift