Medical Manager R&D

Beschreibung

Medical Manager R&D - 12 months contract - Basel

Due to growth and further development a global pharmaceutical company is looking for experienced medical manager to support global R&D clinical studies and facilitate the development understanding of study protocols.

RESPONSIBILITIES:

Responsible for engagement with study investigators involved in clinical studies within their allocated Region, in close collaboration with the Global/Local operational team (GTL, CTM, SM, LTM) and the Global clinical team (SRS, SRP). May support other Regions as required

Establish a collaborative relationships with investigators, through regular on-site and/or remote visits, to facilitate 2-way communication and increase site engagement and motivation.

Throughout development of own network, identify potential new investigators within the assigned Region to be considered for referral, participation in new or existing trials and/or engagement in advisory committees.

Provide support to investigators for any medical/protocol question. Identify any potential site hurdle (e.g. protocol clarifications, medical/scientific questions, operational challenges, resources constraints…) and advise sites on potential study conduct failures (e.g. best practices sharing for screening failures minimization, patient recruitment and retention optimization…).

Develop an in-depth knowledge of the allocated sites status (e.g. recruitment status, patient identification and/or referral process in place, protocol deviations, SAEs …).

Maintain clinical and technical expertise in the therapeutic area, competitor's products and clinical trials (e.g. scientific literature review, congress attendance…).

Ensure close collaboration with internal local stakeholders (operational and medical teams) within the assigned countries.

Share insights gathered from sites and discuss possible protocol enhancement with the respective Global clinical team.

Manage trainings for local clinical teams on disease area and/or compound training, as required.

EXPERIENCE REQUIREMENTS:

PhD, PharmD, DVM, MSc or equivalent degree in Biological Sciences required

Sound knowledge of clinical development processes, clinical trial processes, and regulatory requirements/ ICH guidelines. Hands-on experience on conducting clinical trials is a plus.

Prior experience of working in a matrix organization including interactions with all relevant functions involved in a clinical trial and program (e.g. Biostatistics, Data Management, Operations, Regulatory, Drug Safety, external service providers, etc.) and external customers.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.