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Medical Research Project Manager (Contractor)

İstanbul(Avr.)

İş Yerinde

Job Type

Full-Time

Position Level

Specialist

Department

Operations

Application Count

326 application

Job Type

Full-Time

Position Level

Specialist

Application Count

326 application

Department

Operations

QUALIFICATIONS AND JOB DESCRIPTION

Provide operational, logistical, administrative, financial and scientific support for non-interventional studies (NIS), low- interventional studies (LIS); and Pfizer non-sponsored research, clinical research collaborations, competitive researchgrants and request for pure substances/compound transfer programs.

Work collaboratively with the medical affairs (MA), HeOr, Drug Safety Unit, Medical Quality Oversight, Procurement, Legal and Clinical Study operations to support the conduct of NIS per Pfizer requirements.
Coordinate the high quality management of the assigned NIS in compliance with Pfizer policy and procedures.
Support the preparation of NIS documents as required by the health authority (HA) and Pfizer policy and requirements.
Plan and conduct the investigator meetings and maintain the related documentation in the correct Pfizer repository (repositories) as required by Pfizer policy and procedures.
Facilitate and coordinate the selection of the appropriate study type and its implementation per Pfizer Clinical and Medical Controlled Documents (CMCDs).
Oversee the vendor management including vendor management plans, monitoring plans, data review plans andother requirements per Pfizer policy and procedures.
Manage timely and accurate monitoring, tracking, and recording of NIS in compliance with Pfizer procedures andstated milestones and deliverables.
Track the relevant Pfizer CMCDs and manage the accurate and updated documentation is filed in the relevant Pfizer repository as appropriate and in Trial Master File (TMF).
Liaise with external collaborators, key opinion leaders to obtain the required updates and documentation.
Participate actively in any related audits or inspections or quality reviews.
Manage financial aspects of NIS (e.g. tracking invocing and payment activities etc).

Pfizer non-sponsored research, clinical research collaborations, competititive research grants and request for puresubstances/compound transfer programs:

Handle and process the requests for Pfizer non-sponsored research, Compound Transfer Program, clinical research collaborations, and competitive research grants; act as the main contact between the investigators andPfizer for each of these activities.
Coordinate the overall management of new requests and ongoing projects in line with HA requirements and Pfizer policy and procedures.
Collaborate with local and global MA, DSU, Procurement and Legal to ensure the timely review of the researchproposal, contract development and execution in line with Pfizer requirements, and financial aspects such as payments.
Manage timely and accurate tracking and recording of the project in compliance with Pfizer procedures and stated milestones and deliverables.
Track the relevant Pfizer CMCDs and manage the accurate and updated documentation is filed in the relevant section of Pfizer repository as appropriate.
Operate the timely communication and its documentation with external collaborators, key opinion leaders, investigators and internal colleagues to obtain and document the status updates of these projects.
Manage the projects in compliance with Pfizer policies and procedures regarding Safety Reporting, FCPA, Interactions with healthcare professionals and Data Privacy.
Participate in any related audits or inspections or quality reviews.

İŞ TANIMI

You will be expected to:

Bachelor of science in Pharmacy , Life Sciences or related discipline
Good working knowledge of International Conference on Harmonisation (ICH) GCP guidelines
Fluency both in English and Turkish is required
Proficiency in MS Office Programs
Able to work in matrix environment
A good team player, self and agile learner
Experience in and supporting a multi-disciplinary team would be an asset
Experience in project management and in a cross-functional research environment would be an asset

Preferred Candidate

Years of Experience

Less than 10 years of experience

Years of Experience:

Less than 10 years of experience

Level of Education

Bachelor’s(Graduate), Master’s(Graduate), Doctorate(Graduate)

Level of Education:

Bachelor’s(Graduate), Master’s(Graduate), Doctorate(Graduate)

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Proje Yöneticisi / Yönetmeni Proje Yöneticisi / Yönetmeni Maaşları Proje Yöneticisi / Yönetmeni Nasıl Olunur? Proje Yöneticisi / Yönetmeni Nedir? Proje Yöneticisi / Yönetmeni İş İlanları

Pharmaceuticals industry

Takip Et

Hakkımızda

DÜNYADA PFIZERİnsanların daha uzun, sağlıklı bir yaşam sürmesi ve yaşam kalitesinin yükseltilmesi için çalışan Pfizer, 1849 yılında kuruldu. Bugün 150

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Proje Yöneticisi / Yönetmeni pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.