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Careers in India
DEVELOP YOUR CAREER WITH PPD
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| Clinical Operations Manager |
Supported by a team of Assistant Clinical Operations Managers, you will be responsible for the line management, selection, training, coaching and performance management of clinical personnel in India.
You will act as a source of local knowledge and expertise on country specific laws, practices and processes to ensure compliance to PPD and client SOPs and will support the Project Management team in achieving project deliverables through the allocation of resources in India.
You will need a minimum of 5 years experience in pharmaceutical clinical research including a minimum of 4 years experience as a Clinical Research Associate. You should also have previous line management experience within a clinical operations group.
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| Regulatory Affairs Specialist |
Your primary responsibilities will be to provide regulatory advice on strategy and to manage projects in the provision of regulatory affairs services. The will be the need to liaise with internal and external clients in the provision and marketing of these services.
You will have a degree in Pharmacy or Life Sciences, a higher qualification in a relevant subject and/or post-graduate courses in Regulatory Affairs would be an advantage.
You should have around 5 years in a broad range of Regulatory Affairs projects, a good knowledge of Regulatory Affairs in Asia and/or clinical trials procedures
All applicants will require a working knowledge of the background and application of GCP, basic business computer skills (MS Word, Excel, e-mail, etc) and a full driving licence.
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| Contracts Specialist |
Your role will be to manage the day-to-day processes relating to the Company's Contracts with Hospitals and Doctors, ensuring that time to contract is minimised and that appropriate controls for managing legal, financial and operations risk are adhered to. Responsibilities include participating in management level discussions on risk management, internal and external contract negotiations, finance analysis, in order to prioritize and maximise the Company's contracting efforts. You will be supported in this role by the PPD Contracts team based in Cambridge, UK and therefore will work closely with this team
You will be responsible for ensuring that 'Statement of Agreements' (SOA's) are executed within deadlines, according to PPD's standards on protection of both PPD's and our Sponsor Client's interests, whilst maintaining good relations with all involved in the process. This involves the use of PPD, Sponsor and site templates; identification of material issues and some drafting and negotiation to achieve the stated aim.
You should posess a minimum of one years experience in contract negotiation or contract management (preferably in a service company), a proven ability to manage workload against deadlines allied with demonstrable communication and planning skills and the ability to understand and communicate PPD's contractual position and rationale are all essential. You should also have knowledge of general principles of contract law, and the ability to understand contract language ramifications.
The successful applicant should be of graduate calibre (having a degree and/or experience in line with that expected of a graduate level employee within Law or Life Sciences or qualified through experience to Senior CRA level or equivalent.
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| Clinical Team Manager |
This exciting and unique role could take you to the next step of your career within Clinical Research. The role coordinates all aspects of clinical activities on an international basis. This includes the day to day management and leadership of a team of Clinical Research Associates who are allocated to a project on a Country basis. You will work in partnership with the Project Manager to ensure the necessary training, tracking and quality systems are in place for the clinical team, and be primarily responsible for the clinical deliverables of the Project within agreed timelines and budget. Clinical Team Managers provide contact and support to the project sponsor for all clinical aspects.
We are seeking high performing individuals who enjoy a fast-paced environment and have had Lead CRA experience and exposure to international studies, preferably involving the coordination of CRAs across different countries. With your excellent written and oral English skills you will have exceptional interpersonal and problem solving skills, with the ability to lead CRAs in different countries. You will also have proficient working knowledge of GCP and experience in several medical / therapeutic areas. You must be comfortable working in a matrix management system and have the ability to motivate, mentor and integrate international teams.
Sounds like you? We are seeking highly motivated and skilled applicants who will want to share in our continued growth in the international market place. If you succeed we can offer you the opportunity to grow into enhanced roles within the department and also have examples of Clinical Team Managers who have moved into project management or management of CRAs. We will consider field based applicants which will depend on your experience and your location to a PPD office
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| Clinical Research Associate/Senior Clinical Research Associate |
You will be primarily tasked to set up and monitor clinical trials conducted in India as part of international projects. You should thrive in multi-national project teams and be focused on delivering exemplary levels of customer service.
With a life sciences degree or nursing qualification and at least one year's experience of Phase II-IV trials, you will have in depth knowledge of FDA and ICH GCP requirements.
SCRAs will have a minimum of two years experience, including experience of start-up, monitoring and close-out. As a SCRA you will have the opportunity to mentor more junior CRAs and may be asked to take on project coordination activities as a lead CRA.
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| Research Assistant/Project Assistant |
As a Research Assistant or Project Assistant you will provide vital support for clinical research projects. You will have excellent communication and organisational skills and a self-motivated, flexible and professional attitude. You must be able to prioritise and work well within a multi-national team environment and have an in-depth knowledge of Microsoft Word, Excel and preferably PowerPoint.
Project Assistants will have a good standard of education and two years administration experience.
Research Assistants will have a life science/nursing qualification and at least six months administration experience. The research assistant role will provide the training required to progress and become a Clinical Research Associate. |
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