Senior Site Activation Specialist, hybrid, client-dedicated, Israel

Description

Senior Site Activation Specialist, hybrid, client-dedicated, Israel

Job Summary

Performs assigned activities within the country that lead to start-up of investigative sites in all phases of

clinical trials. Responsible for providing delivery and expertise, with minimal oversight from the Line

Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory

submissions, collection, review and finalization of essential documents required for site initiation and site

activation activities. Accountable local activities are undertaken in accordance with agreed timelines,

allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned

studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees

(ECs). Under the direction of the Project Lead (PL) or Site Activation Manager (SAM) as appropriate, may

directly interact with Customers when receive requirements from RA or other local regulatory party.

Accountable to the PL/SAM at the project level and line manager for deliverables. May act as the Country

Start-Up Advisor (CSA) or as a line manager / mentor for less experienced staff. At a project level, may act

as SAM for local or regional studies.

Job Responsibilities

 General – Responsible for quality deliverables at the country level; follows project requirements and

applicable country rules, with minimal oversight from the SSU Country Manager. Forecasts

submission/approval timelines, ensures compliance and tracks milestone progress in agreed upon SSU

tracking system in real time; if forecasted timelines are not reached analyses data to provide clear

rationale for delays, provides contingency plans to mitigate impact, and escalates the issue as soon as

identified. Monitors financial aspects of the project and the number of hours/tasks available per

contract; escalates discrepancies in a timely fashion. Reviews and complies with Standard Operating

Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated

accordingly and ensures timesheet compliance. Ensures all relevant documents are submitted to the

Trial Master File (TMF) as per company SOP/Sponsor requirements. Ensures continuous improvement

of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions,

essential document collection, communication to Competent Authorities and ECs, etc.). May be

involved in vendor management.

Responsible for one or more of the following functions at the country level:

 Local Submissions Specialist - Follows the project direction and expertise provided by the designated

country start-up advisor (CSA) and PM/SAM. May serve as the primary point of contact for the PM/SAM

(or designee) during start-up on allocated projects. Compiles and/or reviews essential document

packages for site activation and may also be involved in essential document collection from site.

Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local

regulatory authorities or hospital approval submissions as required.

EC and RA, and other local regulatory authorities as needed within the country; includes safety

notifications as required by local rules, with minimal oversight from the SSU Country Manager.

 May act as liaison and facilitator between investigational sites and functional leads for related tasks

and/or issues. Oversee site activation end to end process at country/ site level.

 Country Start-Up Advisor - Acts as Subject Matter Expert for in-country performance within the Site

Start-Up. Acts as country-level intelligence on start-up (SU) and clinical trial regulatory (CTR).

 Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR

team, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions,

notifications to data protection authorities, notifications/applications to any other local/federal/national

body, and import/export license applications where these are obtained with RA applications. In

absence of legal advisor or subject matter advisor for data protection at the country, provides clear data

protection guidance at a country level on data protection statements that need to be included on those

documents which the Sponsor has contracted to the Company start-up group to adapt to local

requirements. This will typically include the Principal Investigator/Informed Consent and the

Confidential Disclosure Agreement/contract template. Provides input in local SOPs and WI. Support

for the creation of internal training materials on for local legislation requirements. Responsible to

identify solutions with EC or CA issue resolution at the country level.

 Local Site ID and Feasibility Support – Provides support site selection lead and PM/SAM to ensure that

the appropriate sites are selected for individual studies based on the requirements of the clinical trial.

 May be asked to perform: Local Investigator Contract and Budget Negotiator - Produces site-specific

contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific

contracts from country template. Submits proposed CTA and investigator budget for site review.

Negotiates budget and contract with site and via Site Contracts Service Centre and SAM with Sponsor

until resolution of issues. Performs quality control and arranges execution of CTAs as well as archival

of documents into repositories and capture of metadata.

 Line management / mentoring responsibilities – As part of developmental plans, it may be requested

to provide support to management in activities such as interviewing and selection, professional

development, performance management, and employee counseling and separations. Advises junior

team members on administrative policies and procedures, technical problems, priorities and methods.

 May act as Country Delivery Lead: Responsible for operational delivery across the county portfolio for

country participation through to site start up and ending in site activation and First Patient

In. Analyses country and site metrics to ensure baseline project deliverables are being met to

facilitate first patient in Sponsor projections; including planned baseline for completed regulatory

green light with fully executed site contracts and increase efficiency in overall project

delivery. Performs operational site level planning, including efficient allocation of resources within

country

 Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company

SOP/Sponsor requirements.

Qualifications

What we’re looking for

 Min Bachelor’s Degree, higher degrees are preferred, and fluency in Hebrew and English.

 Excellent understanding of clinical trial process across Phases II-IV and ICH GCP

 Good understanding clinical protocols and associated study specifications

 Excellent understanding of clinical trial start-up processes

 Project management experience in a fast-paced environment

 Good vendor management skills

 Strong organizational skills with proven ability to handle multiple projects

 Excellent communication, presentation, and interpersonal skills

 Quality-driven in all managed activities

 Strong negotiating skills

 Strong problem-solving skills

 Ability to mentor, lead and motivate more junior staff

 Demonstrate an ability to provide quality feedback and guidance to peers

 Contribute to a training and Quality assurance plan within SSU and update SOPs/WI

 This role is hybrid with office presence 2-3 times per week

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.