Clinical Research Manager

For our client, Switzerland's leading medical device company, we are looking for an experienced Biological Scientist to support the clinical science team as Clinical Research Manager. This is a one-year contract with extension possibility based in Baselland, Switzerland.

Summary:

The focus of this position is to support engagement with investigators involved in the company's clinical studies and facilitate their understanding of study protocols. You will be responsible for the compliance of the assigned clinical study(ies) with department, company and regulatory standards and procedures.

Tasks & Responsibilities:

As Clinical Research Manager you will be a core member of the Cross Functional Trial Team for the allocated studies. You will be responsible for engagement with study investigators involved in clinical studies within their allocated Region, in close collaboration with the Global/Local operational team and the Global clinical team. In addition, you may support other Regions as required.

Furthermore, you will establish a collaborative medical/scientific connection with investigators, through regular on-site and/or remote visits, to facilitate 2-way communication and increase site engagement and motivation. Throughout the development of your own network, you will 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. You will be providing 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…).

Moreover, you will 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 as well as maintain clinical and technical expertise in the therapeutic area, competitor's products and clinical trials (e.g. scientific literature review, congress attendance…). You will esure close collaboration with internal local stakeholders (operational and medical teams) within the assigned countries and share insights gathered from sites and discuss possible protocol enhancement with the respective Global clinical team. You will be managing trainings for local clinical teams on disease area and/or compound training, as required. As requested, you will participate into cross functional teams for evaluation of new product ideas, implementation of business strategies, improvement of processes, etc.

Requirements:

• MD, PhD, PharmD, DVM, MSc or equivalent degree in Biological Sciences
• 5+ years experience in Pharmaceutical Industry; Prior experience in cardiac and/or pulmonary disease area is a plus.
• Sound knowledge of clinical development processes, clinical trial processes, and regulatory requirements/ ICH guidelines.
• 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.
• Excellent computer systems and software skills
• Excellent English

Nice to haves:

• Hands-on experience on conducting clinical trials
• Experience in driving business process improvement projects

General Information:

• Duration: 12 months
• Extension: possible
• Location: Allschwil BL
• Workload: 100%

Interested in this opportunity? Kindly send us your CV today through the link in the advert. Should you have any questions please contact Nastasia Whyte on +41 61 282 22 13 or

Even if this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland. Check out all of Experis' job openings at www.experis.ch.