Medical Affairs Studies Manager/Ti

Bayer Türk Kimya Sanayii Ltd Şti

Job Description

• To contribute to the preparation of medical plan.

• To coordinate budget expenditures and ensure compliance to financial procedures.

• Initiate, drive, coordinate, track, and ensure overall quality of Medical Affairs clinical studies in Turkey.

• Investigator Initiated Research (Preclinical, Phase I, II, III and IV, Observational).

• Initiate meeting with Investigators to discuss on new research proposals.

• Act as an IIR responsible according to the applicable SOP

• Contribute the presentation of the proposal to Regional and Global Medical Affairs for review.

• Discuss with Regional and Global Medical Affairs on the approval of the protocol concept

• Discuss funding commitment with Marketing and Regional/Global Medical Affairs

• Prepare IIR agreement.

• Ensure contracts are prepared and signed in cases where third parties are involved.

• Update the studies in applicable electronic system (such as IMPACT, SIRIUS, Veeva) Liaise with Global Clinical Supplies on logistical issue of clinical trial ie. Drug supplies, delivery of worksheets to site & etc.

• Motivate investigator that recruitment timelines are met.

• Effective resource management and in ensuring time lines are met.

• Ensure clinical trials meet highest standards of ICH GCP and SOPs, as well as compliance to BHC global/local guidelines in terms of medical, ethical and regulatory requirements.

• Activities that are not mandatory and will be performed depending on the needs of the investigator

        -  Support the submission of clinical trials to HA and/or IRB

        - Support study status update to HA 6 and 12 monthly.

        - Assist the investigator on study closure.

        - Initiate study start-up activities

• Non-Interventional studies (NISs)

• Identify the GNIS department projects and check the countries requirements to be part of these plans and act as Local Project Manager (LPM) for global NIS according to the applicable SOP.

• Ensure contracts are prepared and signed in cases where third parties are involved.

• Act as Conduct Responsible for local NIS according to the applicable SOP

• Contribute to the preparation of SOPs for local purposes.

• Align with country medical managers to identify and organize the NISs status

• Work closely together with medical managers to discuss on the study protocol and CRFs.

• Liaise with Global NISs on study documents.

• Submission of NISs to HA and all applicable IRB for their approval and resolve all revision requirements

• Study status update to ECs &HA 12 monthly.

• Ensure that all notifications to ECs and HA are performed in a timely manner.

• Budget Management

• Contract management

• Ensure that time lines are met.

• Ensure that clinical study progress complies with commitments/schedules and regularly analyses the differences observed, alerts the study team and ensures that necessary actions are taken at local level.

• Ensure local investigator meetings are organized for national/international studies and attends when required.

• For internally conducted studies, responsible for site initiation, periodic monitoring and site close out visits and reports.

• Maintain TMF

• Review the visit reports of CROs in a randomly manner. Schedule oversight visits when necessary

• Ensure that payments are done on timely manner according to the Investigator Agreement.

• Ensure the resolution of data clarification with site

• Discuss with Head of Specialized Therapeutics Area when study time lines are compromised.

• CRO selection and CRO management (when applicable)

• Send periodic reports on the status of studies to CMD.