Ofertas de Empleo
Interim Evidence Generation Manager - Respiratory (M/F)
Farmacéutica / Química
Our client believes in the potential of its people and you'll develop beyond what you thought possible. They make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.
The Evidence Generation Manager will take operational responsibility for the Spain MC commitments toward the delivery of GMA and initiated investigator studies and its associated publications, within agreed time, budget (cost and resources) and quality.
The Evidence Generation Manager is responsible of supporting and coordinating local adoptions, timely delivery of proper documents for submissions of external investigators research proposals to GMA GREG teams. Moreover, the position will be responsible of following closely all events of the research reflected in the contract, especially in the case of final reports delivery and publications. The Evidence Generation Manager will also be responsible to secure compliance with our client's Procedural Documents, international guidelines such as ICH/GCP and relevant local legislation.
The Evidence Generation Manager will be the main point of contact for MedEx, Pharmacovigilance and Quality related to ESR processes, ensuring consistency of the deliverables, quality and commitments achievement within the Spain MC during the whole study performance process.
The role requires regular contact and close collaboration with persons of influence and decision-making authority within the Spain MC (especially Medical Affairs Leads and Medical Managers of the Therapeutic Areas) and also at a Global level (especially with the GMA teams, GREG and publications teams).
Finally, the Medical Evidence Generation Manager has to work in deep collaboration with MEDICLIN ESR´s support team, ensuring a smooth communication during all the ESR processes (starting when the proposal is received until publication of the results)
Leadership of the Spain MC GMA studies and ESR´s delivery team and coordination of an allocated delivery to time, quality, budget, project standards, company quality standards, productivity target and scientific requirements:
* Forecast and day-to-day management of study timelines, budget, materials and development of detailed study level plans and center assessment
* Ensure the usage and update of appropriate systems
* Develop and manage local recruitment & contingency risk plans
Coordinate and execute within given timelines GMA and ESR´s studies of Spain MC, in close cooperation with the Therapeutic Area Team.
Establish and maintain key interactions and good communication with applicable internal stakeholders such as MedEx, Pharmacovigilance, Compliance, Quality, Medical Managers, Medical Leads, Medical Director, GMA, GREG and Global Publications teams. .
Close follow up of GMA studies and local ESR´s timelines
Supporting and coordinating local adoptions, timely delivery of proper documents for submissions of external investigators research proposals to GMA GREG teams
Be the reference person for GMA studies and ESR´s in case of local audits and regulatory inspections in liaison the Medical Affairs teams.
Monitor study conduct and progress to proactively identify and resolve issues which may impact delivery of the study to the necessary quality, timeline or budget objectives.
Working according to locally, regionally and globally agreed GMA and ESR policies including processes and use of technical systems related.
Establish and maintain interactions with external key stakeholders such as principal investigators of GMA studies or ESR´s including the facilitation of communications with MCs, to identify and resolve operational issues, facilitate study start-up activities, and ensure study delivery.
As per need help in the formal protocol development and the development of other documents (such as Informed Consents or proper study proposal) as well as any updates/amendments to those documents
Ensure timely entry and/or update appropriate information into our Client's tracking and communication tools (e.g. ESROS).
Ensure the supply of approved study materials to principal investigators or third parties (such as CRO´s) so the development of study protocols follows our Client's regulations.
Contribute to the planning of Evidence Generation programs with the Therapeutic Areas
* University degree in Biological Science or healthcare-related field, or equivalent
* At least 2 years of experience with clinical study delivery/clinical development processes/publications generation
* Knowledge of the pharmaceutical industry and especially of the Medical Affairs departments and its responsibilities
* Experience in project management methodologies including budgetary and resource planning
* Very good knowledge of the clinical study and drug development processes, GCP/ICH guidelines and the local applicable regulations
* Has an appropriate understanding of at least two therapeutic areas or two main indications within one therapeutic area including familiarity with the latest research and KOL
* Experience of at least two or more phases in clinical trials (phase I-IV) or at least two or more types of study designs (e.g. open, double blind, interventional, non-interventional).
* Very good knowledge of oral and written English
* Open to periods of travel throughout the Spain MC and international travels
We offer a 12 month project in an international laboratory