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Site Care Partner – Lead CRA
Location
Belgium
Posted
51 days ago
Salary
0
Seniority
Senior
Job Description
Site Care Partner – Lead CRA
Parexel
• Accountable for site start-up and activation. • Deploy Global Site and Study Operations (GSSO) site strategies by qualifying and activating assigned sites. • Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide Pre-Trial Assessment (PTA) output for site selection. • Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision. • Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation. • Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. (e.g., PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.). • Support country specific ICD review and deployment when applicable. • Ensure follow up activities’ completion post PTA and SIV to ensure site readiness for FSFV. • Partners with site monitor to ensure site monitoring readiness in anticipation of first subject first visit. • Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g., vendor, site contracts and payment issues etc.). • Ensure the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study. • Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators. • Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals e.g., recruitment, data entry timelines etc.). • Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable. • Accountable for study conduct and close-out. • Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions. • Review Site Monitoring Reports and support the site with revision and submission of ICD documents (and amendments). • Working with other roles, maintain system management (e.g., EDC, Shared Investigator Platform, Site Profile, and other systems as applicable) at site level ensuring alignment across platforms. • During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed under DCSO/ Senior SCP supervision. • In addition, the SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current. • Review and manage site practices that differ from client practices and liaise with study management and Business Process Owners as needed. • Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback. • Oversight and management of site deliverables to study targets, i.e., data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e., investigator signatures. • Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks. • Support development and delivery including issue resolution of decentralized capabilities at investigator sites e.g., home health, ePRO, DTP etc. • Assure quality and consistency in the delivery of monitoring and drive efficiencies and best practices for study/region/program. • Support shaping the local clinical development environment with a goal to enhance client reputation in scientific leadership. • May act as a Subject Matter Expert on client systems and processes. • Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships. • Support the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager and Study Management. • Responsible for proactively providing local intelligence. • Provide input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics. • Provide support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies.
Job Requirements
- Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience (estimate at least 5 years’ experience).
- Ability to communicate effectively and appropriately with internal & external stakeholders.
- Ability to adapt to changing technologies and processes.
- Demonstrated networking and relationship building skills and to manage cross functional relationships.
- Demonstrated experience in site management with prior experience as a site monitor.
- Demonstrated experience in full lifecycle activities from start-up/site activation through to closeout.
- Demonstrated knowledge of quality and regulatory requirements for the country the role is based.
- Knowledge of Good Clinical Practice (GCP)/International Council for Harmonization (ICH) Guidelines and other applicable regulatory requirements.
- Ability to manage required travel of up to 75% on a regular basis.
- Proficiency in local language. English is required.
Benefits
- Health insurance
- Professional development opportunities
- Flexible working hours
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• The Site Care Partner I role is a key Pfizer point of contact for investigative sites throughout a study life cycle. • Accountable for site start-up activities through site activation. • Building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies. • Site-level recruitment and accountable for safeguarding the quality and patient safety at the investigator site. • Contributing to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and Pfizer pipeline opportunities under supervision. • Ensuring that sites receive necessary support and engagement, that issues are resolved, and Pfizer’s reputation is upheld throughout study lifecycle. • Coordinating with other roles and functions that will interface with study sites (eg. CRA, Investigator Contracts Lead, Site Activation Partner, Country Operations, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities. • Site quality utilizing and interpreting data from analytic tools, in conjunction with country intelligence and IRMS to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. • Deploying site strategies by qualifying and activating assigned sites. • Supporting processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection. • Conducting study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation. • Ensuring all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. • Ensuring follow up activities' completion post PTA and SIV to ensure site readiness for FSFV. • Partnering with CRA/site monitor to ensure site monitoring readiness in anticipation of first subject first visit. • Establishing and maintaining relationships with Site Organizations and Strategic Partners. • Providing study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g. vendor, site contracts and payment issues etc.) • Ensuring the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study. • Effective site recruitment planning and delivery, consistent with global and/or country plan and local targets.
Role Description The Site Care Partner is a crucial liaison for investigative sites throughout a study's lifecycle, responsible for site start-up, activation, relationship management, recruitment, and quality assurance. This role also contributes to site selection, provides local intelligence, ensures site support, resolves issues, and collaborates with various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and mitigate risks. The Site Care Partner may be expected to support Country Specific Activities that are required to ensure end-to-end clinical trial implementation (start up to close out). Key Accountabilities: - Site start-up and activation - Deploys client site strategies by qualifying and activating assigned sites - Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list and provide site qualification output for site selection - Supports the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered - Collaborates with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices (as applicable) under supervision. - Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required. - Maintains a knowledge of assigned protocols - Conducts study start-up activities at the site level including but not limited to Site Qualification, coordination of site activation checklist items, Informed Consent Form (ICF) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation. - Ensures all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation - Supports country specific ICF review and deployment up to Site Activation - Ensures follow up activities’ completion post Site Qualification visit and SIV to ensure site readiness for First Subject First Visit (FSFV) - Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV - Responsible for relationship building and operational quality of the site - Provides study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g., vendor, site contracts and payment issues etc.) - Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study - Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly responsible with CRA for enrollment delivery during study conduct - Partners with local Regulatory authorities and Study Start up teams to ensure timely completion on country / local registry up to Site Activation - Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners - Intelligence gathering - Provides input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics - Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy in collaboration with study management - Provide regional exploration/territory development growing adjacent opportunities where possible - Provides support to study management to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies - Study conduct and close-out - Reviews Site Reports and related issues - During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed. - Informs and educates investigator sites of client pipeline opportunities that may be a good fit - Supports development and delivery including issue resolution of decentralized capabilities at investigator sites - Demonstrates leadership within the local clinical development environment with a goal to enhance client reputation in scientific leadership - May act as a Subject Matter Expert on client systems and processes. - Actively pursues possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships - Ensures clear and open communication with the study team - Supports the CRA to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Study Management Qualifications - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation, and interpersonal skills - Ability to manage required travel - Demonstrated networking and relationship building skills - Demonstrated ability to manage cross functional relationships - Ability to communicate effectively and appropriately with internal & external stakeholders - Ability to adapt to changing technologies and processes - Knowledge of country requirements for GCP that may be different to those of client procedures - Effectively overcoming barriers encountered during the implementation of new processes and systems - Identifies and builds effective relationships with investigator site staff and other stakeholders - Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization - Effective in managing cross functional relationships Requirements - Demonstrated experience in site management with 5+ years prior experience as a CRA in a clinical research or pharma organization - Oncology monitoring/CRA experience is required - Experience reviewing monitoring reports is required - Demonstrated experience in start-up activities through site activation - Demonstrated experience in conduct and close out activities - Demonstrated knowledge of quality and regulatory requirements in applicable countries Education - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (at least 5 years’ experience) - Proficiency in local language preferred. English is required Company Description Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Role Description Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. - Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. - Demonstrates diligence in protecting the confidentiality of each subject/patient. - Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP). - Conducts Source Document Review of appropriate site source documents and medical records. - Verifies required clinical data entered in the case report form (CRF) is accurate and complete. - Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. - Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. - Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. - Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. - Verifies issues or risks associated with blinded or randomized information related to IP. - Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. - Reconciles contents of the ISF with the Trial Master File (TMF). - Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. - Supports subject/patient recruitment, retention and awareness strategies. - Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met. - Must be able to quickly adapt to changing priorities to achieve goals/targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. - Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. - Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. - For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. - Additional responsibilities include site support throughout the study lifecycle from site identification through close-out. - Knowledge of local requirements for real world late phase study designs. - Chart abstraction activities and data collection. - Collaboration with Sponsor affiliates, medical science liaisons and local country staff. - The SMA II may be requested to train junior staff. - Identify and communicate out of scope activities to Lead CRA/Project Manager. - Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience. - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - Must demonstrate good computer skills and be able to embrace new technologies. - Excellent communication, presentation and interpersonal skills. - Ability to manage required travel of up to 75% on a regular basis. Requirements - As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. - Failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. Benefits - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture – where you can authentically be yourself. - We are continuously building the company we all want to work for and our customers want to work with.
Senior Partner Programs Lead
MongoDBMongoDB, originally called 10gen, is a software development company. Since 2007, MongoDB has created an open-source, document-oriented database to help clients
Role Description We are building a first-of-its-kind ISV partner motion at MongoDB, and this role is a founding part of that effort. As Sr. Partner Manager for ISVs, you will own the identification, development, and scaling of partnerships with independent software vendors across two key categories: - Industry-specific ISVs building vertical applications in markets like financial services, healthcare, insurance, retail, and manufacturing - Horizontal AI-native ISVs developing platforms and tools that serve builders across industries This is a greenfield opportunity. You will help shape the program from the ground up, define how MongoDB goes to market with ISV partners, and build a repeatable playbook that scales. You will move from initial outreach and product-market fit validation through to field distribution and co-sell execution with MongoDB's sales organization. This role requires a rare combination of business development instinct, commercial acumen, and the ability to work cross-functionally in a fast-moving environment. The position is remote and open to candidates located in New York City, NY. Qualifications - 6+ years in business development, partnerships, or ISV program management - Demonstrated experience managing complex partnership initiatives from sourcing through GTM execution - Understanding of how enterprise software is bought and sold - Ability to translate a technical integration into a field co-sell motion that generates pipeline - Technical aptitude to understand how ISVs build on data platforms - Strong communication skills with diverse audiences - Ability to build trust quickly with external partners and internal stakeholders Requirements - Identify, recruit, and activate high-potential ISV partners across both vertical and horizontal categories - Source and structure partnership agreements, define joint value propositions - Validate initial product-market fit with new ISV partners - Develop and execute partner GTM plans - Drive adoption and distribution of validated integrations - Manage ongoing partner success by tracking adoption and performance - Contribute to the design and evolution of MongoDB's ISV partner program - Build reusable assets such as partner playbooks and field guides - Partner closely with Sales, Pre-Sales, Product, Marketing, and Legal teams - Maintain a deep understanding of the vertical SaaS and AI application landscape - Represent MongoDB at relevant industry events and conferences Success Measures - 3 Months: Develop a strong working knowledge of MongoDB's product, sales motion, and existing ecosystem. Identify and prioritize a first wave of ISV partner targets. - 6 Months: Activate initial ISV partnerships with defined joint value propositions and early co-sell plans. - 12 Months: Demonstrate measurable business impact through ISV partner-influenced pipeline and validated integrations. Benefits - Equity - Participation in the employee stock purchase program - Flexible paid time off - 20 weeks fully-paid gender-neutral parental leave - Fertility and adoption assistance - 401(k) plan - Mental health counseling - Access to transgender-inclusive health insurance coverage - Health benefits offerings



