Medical Affairs Observational Studies Pm

**Medical Affairs Observational Studies PM**

**Position purpose**

The OS Project Manager (OS PM) is the responsible person for the management, conduction and execution of locally developed observational studies (OS) and global OS. To perform this activity, the OS PM must ensure the proper performance of the tasks listed below:

- tight control of the study budget;
- required logistic coordination (including external providers)
- timeline schedule and forecasting
- all mandatory processes must be carried out to the highest quality standards, complying with current legislation, good clinical practice standards and company's SOPs.

The OS PM is responsible to inform the Medical Advisors ensuring that they are properly updated through monthly study highlights.

**Major tasks and responsibilities of position**

**Project Coordination Project Manager**
- Responsible of the setting up, management and continuous tracking of local and global OS where she/he is involved.
- To conduct the internal approval process for new local OS proposals, not just strategic approval (first tier review) but also protocol approval by Bayer Protocol Review Committee (PRC) in order to get the internal green light before any Health Authority or Ethic Committee submission take place.
- Review the achievement of the scheduled project milestones and responsible to inform internal stakeholders such us procurement, legal, medical managers, pharmacovigilance about if applicable.
- Before the CRO agreement signature, she/he is responsible about the services stated in the CRO/EP contract align with the needs of each study planning.
- Keep a close relationship with Key Opinion Leaders involved in OS under her/his responsibility over all study course. Conduct the investigators training process, investigators meetings and other relevant contacts with the physicians involved in the OS.
- Responsible of the study status reporting in the required tools (IMPACT, Montblanc, MAS&C SharePoint) about key study data such us patient recruitment status, study phase, budgetary control and forecasting.
- To check the quality of the CRO/EP services provided such us protocol submission to EC and Health Authorities and site agreements, proper maintenance of the OS Master Dossier and study archive.
- To conduct the CRO/EP training in the BAYER SOPs.
- Responsible of study highlights, before its internal distribution.

**Support and Information for the Therapeutic Areas**
- Feasibility study of new study proposals from the operational and regulatory perspective. Budgetary forecast prediction. Operational a regulatory requirements advisor.

**Compliance with the Budget and Optimisation of Contracts**
- Responsible of budget control allocated to each OS and milestones achievements.

**Responsible of the Correct Implementation of the Study**
- responsible that the OS conducted comply with all legal regulations and good clinical practices and that their execution is adapted to the provisions set out in the protocol, maintaining the highest standards of scientific accuracy. Therefore, as well as the monitoring and control of the CROs and other EP, bearing in mind OS PM will assure the necessary quality controls according to the quality review plan and medical review plan of each the study.
- To check and propose solutions if the study is not completed within the proposed time periods.
- If any incident occurs during the study, the OS PM and OS Lead PM will be the contact persons for Pharmacovigilance, Medical Advisors, BU Heads or the Sales force for its resolution.

**Continuous Learning**
- Be trained in the methodology of post-authorisation studies, be up-to-date regarding the administrative problems that arise due to their execution in each community and the factors that assist their start-up (pharmacoeconomic, quality of life indicators, etc.)

**Qualifications**

(Education, skills, experiences and personal characteristics necessary for success in this position)

Academic Training:
Degree or Diploma in Health Sciences

Languages: Advanced level of English & Spanish.

Additional Training:
Training in Clinical Trials

Training in Good Clinical Practices

Training in Post-authorisation studies

**Experience**:
At least 3 years of experience as Study Monitor/Coordinator (Local or International)

**Skills**:Negotiation skills

Aptitude for interpersonal relations

Team-work orientated

Aptitude for oral and written communication

Results-driven

Great sense of responsibility

Pro-active, enthusiastic, flexible

Team Leader, decisive

Methodical and organised person

Commercial vision

Capacity to improve

Good skills with office programs

**Application Period**:

- 15 días**Reference Code**:

- 785721**Division**:

- Pharmaceuticals**Location**:

- Spain : Cataluña : Barcelona**Functional Area**:

- Clinical Development & Operations**Position Grade**:

- GP7**Employment Type**:

- Regular**Work Time**:

- Regular**Contact Us**

**Address**

**Telephone**

**E-Mail*