- Oversight of CRO / other vendors and study management-
- Oversees CRO pre-site selection and site initiation, interim close-out and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance
- Assists in the management of CROs and other vendors to ensure project requirements are met
- Ensure proper overview and communicate to teams (including on-time or high quality) of monitoring activities, data flow, data validation
- Evaluating and monitoring the project progress and resources to ensure projects are on time and within budget
- Reviewing operational aspects of trial activity and clinical protocols, providing oversight for trial implementation activities
- User of systems and business technologies to document and track study and user progress
- Assist in review of clinical protocols, amendments, informed consents, CRF/source document design, protocol specific training documentation, administrative letters etc.
- Oversee TMF management and review TMF documents as necessary
- Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS etc.)
- Work with QA for CAPA documentation and resolution
- Assists in forecasting of IP requirement during the study and prepare IP requisition.
- Assists in preparing and obtaining approval for clinical trial budget and for any change in the budget during the study; annual forecasting and tracking of spend.
- Assist in overall project planning and execution for clinical protocols
- This position requires approximately 10% travel to domestic and international locations
- Coordinate with cross functional teams (e.g. Medical monitor, Regulatory Affairs, supply chain, statistics, Data management, QA and QC, CRO, vendors etc.)Works cross-functionally and with external vendors to proactively manage the execution of the clinical trials
- Provide administrative support around meeting management, assembly of presentations for Investigator meeting and CRO/vendor kick-off meetings as required
- Interacting with various internal and external teams to facilitate successful project completion
- Assist in managing study team meetings with both internal and external resources
- Strong problem-solving and decision-making capabilities, with the ability to navigate complex challenges.
- Industry Awareness: Stay current with industry trends, emerging therapies, and advancements in clinical trial methodologies.
- Interpersonal Skills: Collaborative and able to build strong relationships with internal teams and external partners.
- Contributes to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.
- Minimum 6 years clinical study management experience with at least 2 years direct multinational study management experience
- 2 + years dermatology experience
- Ability to manage delegated aspects of assigned clinical trials
- Ability to manage CROs and Clinical Study vendors
- Bachelor's level degree in life sciences, pharmacy or nursing
- Robust understanding of ICH/GCP, and knowledge of regulatory requirements
- Proficiency in MS office including Word, Excel, PowerPoint and other applications
- Strong clinical study/project management skills
- Outstanding communication skills, both verbal and written
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Field Biologist
Found in: Appcast Linkedin IN C2 - 3 days ago
Dhanuka Agritech Ltd. Gurugram, IndiaRole - having experience in Field Trials in Agrochemical · Responsibilities - · field trials for dose setting of Pesticide insecticides/fungicides/herbicides at fields depending upon the requirements of the area · the approval for product efficacy in order to register the produc ...
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Assistant Manager – Finance, Accounting
Found in: Talent IN 2A C2 - 3 days ago
Brillon Consumer Products Pvt Ltd (Formerly known as SC Johnson). Gurugram, IndiaSummary: · The purpose of the role is to provide play an active role in financial accounting, taxation (Bothe direct & Indirect) , and taking care of the compliances under laws namely Companies Act, Income Tax Act & RBI · Role and Responsibilities: · Responsible for Month End, fu ...
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Brand Manager
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RSPL Group Gurugram, IndiaRSPL-HCD brings you an exciting opportunity for Brand Manager profile. · Incumbent will be responsible for developing brand strategies, marketing plans, and product innovations to drive product growth in respect to Baby Care/ Diaper Brand. This role includes accessing current bra ...
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Brand Manager
Found in: Talent IN 2A C2 - 1 day ago
RSPL Group Gurugram, India#JoinRSPLinto Brand Management · This individual will be responsible for developing brand strategies, New product launches, ATL & BTL, Consumer Insights, GTM plans and product innovations to drive product growth. They should feel comfortable working cross-functionally to execute ...
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Finance Executive
Found in: Talent IN 2A C2 - 4 days ago
Namshi Gurugram, IndiaWho are we? · Are you ready to embark on an exciting journey in the world of fashion and e-commerce? Namshi, the leading online multi-brand fashion and beauty platform in the Middle East, is looking for talented individuals like you to join our dynamic #NamFam Finance Team, based ...
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Finance Manager
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Kunskapsskolan India - Schools Gurugram, IndiaDesignation - Finance Manager · Responsibilities and Duties- · Accounts Receivable · Ensuring streamlined and efficient fee invoicing quarterly/monthly on due dates and managing the payment gateways. · To ensure that fee-due notices are sent by the respective school within the st ...
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- Senior Account Executive
Found in: Talent IN 2A C2 - 6 hours ago
Fairdeal Market Gurugram, IndiaRole- Senior Account Executive · Experience: 3+ Years · Location- Sector 67, Gurugram · About the Fairdeal.Market · Fairdeal is building a data-led retail distribution network to provide a full-stack offline distribution service to brands. It is also helping regional and interna ...
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Oracle Developer
Found in: Talent IN 2A C2 - 4 days ago
NITS Solutions Gurgaon/Gurugram, India permanentJob Responsibilities : · - 2-3 years of overall design and development experience with large-scale database systems in a 24X7 Production environment. · - Minimum 3-4 years of Oracle 11g, 12c, SQL, PL/SQL development experience with exposure to ETL Processes. · - Proficient in Ora ...
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Senior Accountant
Found in: Talent IN 2A C2 - 2 days ago
Alike Gurugram, Indiais a passionate bunch of people, working hard to make it easy for everyone to travel like the people they like. We do this by helping travel content creators share their travel stories from their personal travel studios and by assisting travellers to find and book their most pref ...
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Senior Manager
Found in: Talent IN 2A C2 - 2 days ago
PeopleStrong Gurugram, IndiaWho are we? · PeopleStrong is Asia Pacific's leading, and the most comprehensive Human Capital Management SaaS platform. We focus on delivering a unique employee experience, decisions that are driven by data-driven decision-making, and agility for businesses. · What do we do? · W ...
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Sheet Metal Die Development
Found in: Talent IN C2 - 5 days ago
Maruti Suzuki India Limited Gurgaon, India Full timeDivision : Body Engineering (BDE) | Production Engineering (PE) · Department : Press Engineering (PSE) · Job Location : Gurgaon / Manesar · Job Title : Asstt Mgr/Dy Mgr (Sheet Metal Die Development - Press Dies) · Educational Qualification : BTech/Diploma in Mechanical/Production ...
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Senior Associate
Found in: Talent IN 2A C2 - 5 days ago
Urban Company Gurugram, IndiaAbout the company : · Urban Company is a tech-enabled home services marketplace. Customers use our platform to book services, such as beauty treatments, haircuts, massage therapy, cleaning, plumbing, carpentry, appliance repair, painting , which are delivered in the comfort of th ...
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Brand Manager, VMS
Found in: Appcast US A2 ECP - 4 days ago
Haleon Gurgaon, India Full timeHello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren ...
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Legal Associate
Found in: Talent IN 2A C2 - 5 days ago
Convosight Gurugram, IndiaJob Description: · A legal associate is a licensed attorney who provides support to senior lawyers in a variety of legal matters. · They typically have 3 or more years of experience working in a law firm or corporate legal : · Manage client cases from start to finish, including c ...
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Principal Clinical Study Manager
Found in: Talent IN C2 - 5 days ago
Haleon Gurugram, India Full timeJob Purpose: · Principal Clinical Study Manager is at the heart of our Evidence Generation activities and aligned to our Cultural pillars of Go Beyond, Do What Matters Most and Keep it Human. The role provides operational leadership to the Clinical Study Team and is responsible ...
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Automotive Paint Quality Specialist
Found in: Talent IN C2 - 3 days ago
Maruti Suzuki India Limited Gurgaon, India Full timeVertical : Production Engineering (PE) · Department : NMQ · Job Location : Manesar/Kharkhoda · Job Title : AM/DM · Job Role : Automotive Paint Quality Specialist · Educational Qualification : BTech/BE in Paint Engineering/Production Engineering/ Chemical Engineering. · Work Exper ...
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Press Die Design
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Maruti Suzuki India Limited Gurugram, India Full timeDivision : TDE (Tool & Die Engineering) · Department : TDSG (Tool Design) · Job Location : MSIL, Gurgaon · Job Title : AM/DM (Press Die - Design) · Educational Qualification : BE/BTech/MTech (Tool Design/Mechanical/Production); Degree in Tooling (Tool & Die making from TRTC, CITD ...
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BlackOpal - Chartered Accountant - Real Estate
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Blackopal Consultants Pvt Limited Gurgaon, IndiaChartered Accountant - Real Estate · Position Summary: · - Handle the Accounts and Finance operations of the company entailing preparation and maintenance of statuary books of accounts. · - To manage Investors and Banking relationships · Minimum Requirements: · - CA with at l ...
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Senior Research Analyst
Found in: Talent IN C2 - 5 days ago
Lifelancer Gurugram, India Full timePOSITION SUMMARY · The role of a senior analyst a critical element to any project. You will be supporting assistant managers and upwards. The fundamental tool of any well executed project is good quality data. The analyst plays a crucial role in making sure that high quality data ...
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Injection Mold Design
Found in: Talent IN C2 - 3 days ago
Maruti Suzuki India Limited Gurugram, India Full timeVertical : Production Engineering (PE) · Division : TDE (Tool & Die Engineering) · Department : TDSG (Tool Design) · Job Location : Gurgaon · Job Role : · 1) Independently handling Mold flow & cooling analysis (simulation) & mold design of big plastic parts like car bumper / Inst ...
Global Trial Manager - Gurugram, India - SUN PHARMA
Description
Sun is seeking a Global Trial Manager, Clinical operations within its clinical development Team in India. The Global Trial Manager, Clinical Operations will report into Global Trial leader, Clinical Operations. Under the direction of the Global Trial leader, Clinical Operations, the Global Trial Manager, Clinical Operations will assist Global Trial leader in providing global, regional or complex local management of Sun Pharmaceutical's clinical trials. This role will be Instrumental in providing operational oversight of assigned project(s) for end-to-end clinical trial management including start-up, execution, close-out, and study report finalization. Responsibilities include reviewing study plans and study documents, monitoring study progress and data quality and coordinating trial tasks and timelines, ensuring all teams and tasks are on track.
Responsibilities:
Collaboration with cross functional teams-
Soft skills-
Qualifications: