Clinical Operations Lead (Site Relationship Partner) – Hungary, Sponsor-dedicated
Job title: Clinical Operations Lead (Site Relationship Partner) – Hungary, Sponsor-dedicated
Company: Syneos Health
Job description: Clinical Operations Lead (Site Relationship Partner) – Sponsor-dedicated
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
- #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Responsible for relationship building and management
- Usher investigator sites through site activation and study activities from study start up to close out.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Act as the main point of contact for all site- and study-level questions, liaising with and escalating to appropriate teams to respond and resolve questions. Follow up and close issue status with investigators to ensure awareness of resolution.
- Inform and educate investigator sites of company pipeline opportunities that may be a good fit.
- Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.
Responsible for proactively providing local intelligence
- Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
- Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics.
- Review and manage site practices that differ from company practices and liaise with study teams and study management.
- Understand targeted site criteria as well as services delivered to target sites. Track that all such services are provided consistently and in a timely manner.
- Recommend potential targeted sites and conduct follow up with those sites as required.
Accountable for study start-up, activation, and execution to plan
For targeted sites
- Deploy GSSO targeted site strategy by qualifying and activating targeted sites, while coordinating company functions to standardize processes and deliver activation in line with the targeted site strategy.
- Confirm (and educate where needed) that sites are familiar with Pfizer requirements for study start up and facilitate the availability of MSAs when feasible.
- Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
- Closely monitor and support study start up activities including review of key documents (e.g., local Informed Consent Document template), to address regulatory and/or ethics committee questions for targeted sites.
For all sites:
- Provide enrollment 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 confirm colleagues.
- Support database release by facilitating query resolution, as needed.
Responsible for CRO and Study Management Interface
- Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Excellence Partner and Study Management.
What we’re looking for
- A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience and/or quality management experience.
- Skills in more than one language are an advantage in this role. English is required.
- Experience with drug development and monitoring (preferred)
- Experience implementing centrally designed and developed initiatives on a local basis
- 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
- Demonstrated success in prior scientific/technical/administrative roles
- Demonstrated experience in site activation
- Demonstrated networking and relationship building skills
- Demonstrated ability to manage projects and cross-functional processes
- Ability to communicate effectively and appropriately with internal & external stakeholders
- Ability to adapt to changing technologies and processes
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
#MB – LI1
Job date: Wed, 26 May 2021 01:03:58 GMT
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