Description:
TalentSource Life Sciences is currently searching for a Clinical Lead - Site Care Partner to join one of our partner companies. Our client is a global biopharmaceutical company which brings therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products.

As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

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 continuous support from your TalentSource Line Manager.

The Site Care Partner will be the main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. He/she is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, the Site Care Partner will utilise and interpret data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. The Site Care Partner is also accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place. He/she is accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and the company's reputation is that of "Partner of Choice."

The Site Care Partner proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and pipeline opportunities. The consultant is accountable for study start up, activation, and execution to the plan for targeted sites. In addition to be the main point of contact, the consultant will help coordinate with other roles and functions that will interface with target sites, thereby, simplifying site communications and enhancing overall visibility into and confidence of quality of site-level activities.

Main Responsibilities:

Responsible for relationship building and management

• Guide investigator sites through site activation and study activities from study start up to close out
• Maintain regular communications with investigator sites
• Act as the main point of contact for all site- and study-level questions

Responsible for proactively providing local intelligence

• Provide country/regional level input to country outreach surveys including protocol feasibility
• Provide country/regional level input to country strategy, feasibility and protocol design
• Apply clinical development strategy in the assessment of country and site selection at the asset level

Accountable for study start-up, activation, and execution to plan for targeted sites

For all sites

• Provide enrolment support and ensure progress by responding to start up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level
• Maintain a thorough knowledge of assigned protocols
• Proactively identify, manage and escalate site issues related to study delivery, triaging and coordinating communications and resolution efforts by colleagues
• Support database release by facilitating query resolution, as needed
• Actively pursue possible efficiencies and develop best practices in the delivery activities for site start up and performance at the targeted site level to increase investigator/site satisfaction and strengthen targeted site relationships with the company
• Seek assignment to complex protocols due to demonstrated capability in responsibilities

Responsible for CRO and Study Management Interface

Responsible for process, standards, and oversight

• Responsible for site and monitoring quality, regulatory and GCP compliance
• Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution
• Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks

Protocol Site Oversight

• Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality
• Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements
• Seek assignment to complex protocols driven by demonstrated capability in role

Site and Study Management Interface

• Support local Investigator relationship management with the Site Relationship Partner
• Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team
• Support the resolution of operational obstacles at the site / country level in order to advance the site and study deliverables

Education and Experience:

• A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology
• At least 7 years of clinical research experience and/or quality management experience
• Site Management/Monitoring (CRA) experience (preferred)
• Project management experience preferred in the clinical development area
• Ability to lead, troubleshoot and influence for delivery
• Independent approach
• Demonstrated knowledge of quality and regulatory requirements for applicable countries
• Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation
• Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment
• Proactively manages change by identifying opportunities and coaching self and others through the change
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organisation
• Motivates through example, commitment, loyalty and enthusiasm
• Willingness to travel within country and region

The Benefits of Working for TalentSource in The Netherlands

• Competitive Salary
• Group health insurance
• Great pension scheme
• 30 Holidays per annum
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Monthly meetings with line manager
• Full performance and development process with end of year reviews
• Team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

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=HQ00002494

or please contact Vanessa.Verdickt@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.

Key words: Site Care Partner
Skills: Clinical Data Manager, Senior Clinical Data Manager, Clinical Data Management Location: Netherlands Share:

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