Skip to main content

This job has expired

Clinical Operations Director, Switzerland - S

Employer
ClinChoice
Location
Switzerland
Salary
Competitive
Start date
21 Apr 2021
Closing date
21 May 2021

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Description:
TalentSource Life Sciences, the CROMSOURCE flexible resourcing dept., is currently working with one of our partner clients to recruit an experienced Clinical Operations Director to join their team as their permanent full-time employee in Switzerland, Greater Zürich area. This client is a leading medical device advisory firm with headquarters in Washington DC, mainly oriented towards the cardiovascular area and also orthopedics, spine, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.

This position will have a focus on the planning, sourcing, and operational conduct and oversight of cardiovascular device trials, and will support the expansion of the firm's operations and expertise for all aspects of the development and execution of clinical trials/protocols in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

Main tasks and responsibilities:
  • Responsible for the execution of assigned clinical studies, which includes operational oversight of submission(s) to achieve timely approval, internal and external resource planning, vendor coordination, monitoring schedules and report approvals, outcomes data readiness, support of safety reporting and the organization and planning of study-specific meetings
  • Directs clinical study teams to ensure that clinical trials are conducted according to company SOPs, within given timelines, within the assigned budget, are conducted in a legal and compliant manner, and are following the highest quality and ethical standards
  • Responsible for informing and engaging the VP, International Clinical Affairs & Cardiovascular Research in cases of expected or manifest internal and external obstacles that cannot be effectively addressed and/or overcome autonomously
  • Establish and maintain effective working relationships with clients/Sponsors, investigators, site personnel and key opinion leaders. Coordinate and facilitate investigator meetings, study team meetings, etc
  • Responsible for ensuring an appropriate level of transparent communication within the European clinical group and the team in the USA by coordinating and conducting regular meetings
  • Responsible for the coordination of European operational approaches with practices and procedures as established by the headquarters in the US to achieve best possible leverage and integration
  • Responsible for material contribution to the department's development planning, performance management and training for clinical research personnel
  • Responsible for maintenance of an effective study monitoring and support team including hiring, performance evaluation, development, and management of direct reports
  • Responsible for preemptive budget planning and financial decisions within scope of assigned responsibilities
  • Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
  • Collaborate with other company business units on business development initiatives, including proposal development and bid defenses


Education and Experience:
  • Scientific, life-science, or medical degree and 8 or more years of experience with the management of clinical studies in the cardiovascular field, or equivalent combination of education and experience
  • Experience and/or knowledge of the management of the clinical research processes for medical device (or drug) trials in the cardiovascular field leading to a CE-mark or PMA submission is critical
  • Thorough understanding of clinical trial design, statistics and regulatory approval processes is required
  • Line management experience required, including management of remotely located direct reports and external vendor organizations


Skills:
  • Excellent proficiency in written and oral English and at least one other European language is a definite asset
  • Computer literacy and information management, especially the mastering of Word, Excel, PowerPoint, Outlook, and internet software
  • Good communication skills, upstream and downstream through all levels of the organization and clients
  • Energetic, courageous, well-organized, good interpersonal skills, ability to develop strong working relationship with colleagues
  • Well-developed emotional intelligence, excellent team player
  • Flawless ethics and commitment
  • Leadership skills characterized by results and specific achievements
  • Strongly goal-oriented and highly motivated with a high energy level
  • Travel required (approximately 30%)


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002532

or please contact Rocio.EgeaMota@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Medical Devices, CRO, Contract Research Organisation, Clinical Operations Director, Clinical Research Director, Clinical Project Director, Cardiovascular
Skills: Cardiovascular, Clinical Operations Director, Clinical Research Director, Clinical Research Organisation, CRO, Medical Devices Location: Switzerland Share:

LinkedIn Facebook Twitter Email

Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert