Clinical Project Manager
Location: Cologne Area, Germany
Title: Project Manager
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Site Engagement Manager to strengthen the team of our Top 10 Pharmaceutical Companies.
Site engagement is a critical component in the execution of a clinical trial. Engagement of highly motivated clinical investigators will enable sponsor to maximize efficient and timely delivery of sponsor's clinical trials. This position is responsible for contributing to an industry leading site engagement team at our Sponsor.
The Site Engagement Manager is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following:
- Define and implement strategies for engaging clinical sites and investigators
- Characterize and understand the attributes of a good clinical site versus a poor performing site
- Engage clinical sites to develop build, and maintain relationships with investigators/staff to ensure continued performance and capitalize on site expertise
- Evaluate, screen and develop high quality investigative sites to support sponsor's clinical development programs
- Ensure collaboration with key internal & external stakeholders, as well as third party vendor
- Ensure industry best practices consistent with all applicable guidelines and regulations
Main tasks and responsibilities
- Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Clinical Team and key internal stake holders throughout the life cycle of clinical trials
- Support clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of trials
- Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of Sponsor and its activities thereby increasing their desire to partner with Sponsor
- Single point of contact for institutions to resolve business process barriers.
- Assist sites with enrolment barriers by reinforcing protocol specific site recruitment plans
- Communicate regularly with global Site Engagement Team
- Support assigned studies from a regional and cultural perspective & support study teams with quality related visits as needed
- Work with strategic partners to ensure alignment on systems and processes for identifying and engaging sites
- Interact/train new investigators to work on clinical trials
- Develop partnerships (institutions and key investigator relationships)
- Attend key therapeutic trainings/meetings and/or industry training
- 0.7 FTE required - we can consider contractors for this role.
- Bachelor Degree
- Previous experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role (e.g. clinical project manager, study director/coordinator, clinical research associate, patient/site engagement companies)
- Proven track record of success on cross-functional projects in a global environment.
- Good working knowledge of GCP guidelines in different regions
- Travel including overnight stays, possibly global, up to 50%.
- Strong facilitation skills
- Continuous improvement mindset
- Results oriented
- Ability to analyze, synthesize, and clearly present information to individuals and groups
- Customer orientation
- Creative “out of the box” thinker with conceptual strengths, who will challenge the status quo to improve
- Clear and articulate verbal, written and presentation skills with excellent command of the English and/or language
- Comfortable with reviewing/understanding clinical protocols
- Scientific and technical knowledge:
- GCP and regulatory environment
- Medical knowledge and research expertise
- Ability to work independently, to solve problems at all levels of difficulty or uniqueness
- Ability to manage conflict and achieve consensus in a group through complex and thorough discussion
- Regular interaction with various management levels on issues relating to site engagement, patient recruitment, etc.
If you have the experience needed for this position, please apply directly to our website attaching your CV in Word format: https://www.talentsourcelifesciences.com/job-information/?job-id=Hq00001467
Why TalentSource Life Sciences/CROMSOURCE?
CROMSOURCE is a family-owned, high quality, ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all 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 clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Associate Project Manager, Clinical Manager, Clinical Operations Manager, Clinical Project Manager, Clinical Research Associate Manager, Clinical Study Manager