Synthes GmbH

About johnson & johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Global Services Associate will work to resolve global client inquiries, concerns and issues regarding HR processes and policies through phone, email, web-form, and chat. As a Global Services Associate you will work to meet all expected service levels and business performance goals, performing a whole range of services and fully documenting all cases in the Case Management system. You will also support the J&J employees and HR community regarding all inquiries related to employee programs and services, HR policy, process, and procedures including navigational support working with the Team Lead of Contact Center on customer concerns. Major Duties and Responsibilities: Receive inbound inquiries via multiple channels (phone, email, web-form, chat), clarify the need, answer the inquiries and assist in the resolution of concerns. Access enabling technology to complete client inquiries and transactions. Fully document all cases in case management application. Raise complex transactions to Tier 2 for resolution or contact with third party vendors as appropriate. Raise client service issues to the Team Lead, supervisor or manager as necessary. Take ownership of all Contact assigned tasks, initiatives, and inquiries and assure that they are resolved and completed expertly and with a higher level of quality. Assist and support users / customers to make effective use of self-service options, systems, products, services, etc. in accordance to drive rapid resolution and empower customers; educate and inform customers of the full range of GS HR available to them. Attend to and process customer inquiries and request by applying Global Contact standard operating procedures and utilizing analytical skills for resolution. Respond to requests / inquiries from customers (prioritizing as appropriate) and executes on the key tasks and activities within the HR Contact in accordance with defined procedures and guidelines. Investigate issue areas and determine methods of mitigation to resolve problems within acceptable timeframes, routing or raising inquiries as appropriate in order to uphold effective and timely resolution. Develop understanding of Global Services operations and the Johnson & Johnson organization. Continuously improve call handling skills, systems knowledge, and communications skills, thus, improving customer service levels. Identify Contact point on improvement of daily operational processes and provide support to implement these initiatives by highlighting and discussing key changes/improvement programs with the Contact Center team Lead. Supply positively to a knowledge sharing environment by documenting and sharing all consequential working experiences with Contact issue resolution for knowledge database future reference. Communicate and interact effectively with customers and team members of the Global Services HR team(s); develop credibility and trusted mutually respected relationships with customers, supervisors, and co-members. Interact and collaborate with customers, vendors, service providers, and other third parties as applicable in relation to the activities and dependencies within the Contact area.

Global Clinical Operations (GCO) Senior Site Manager (1/2) Position Summary: A Senior, Site Manager is a mid-level site management role with typically 3-5 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. A Senior, Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Senior, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. A Senior, Site Manager may contribute to process improvement, training and mentoring of other Site Managers. A Senior, Site Manager is generally expected to be able to operate independently with little or limited supervision. Principal Responsibilities: 1 Acts as primary local company contact for assigned sites for specific trials. 2 Actively May participate in site feasibility and/or Site Qualification Visit. 3 Attends/participates in investigator meetings as needed, may be expected to help prepare meeting materials and may be required to present at the IM. 4 Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Able to implement and execute all tasks independently with little or limited supervision. 5 Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe. May be required to help provide solutions to challenges faced in other sites in the country. 6 Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. 7 Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct. 8 Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. 9 Arranges for the appropriate destruction of clinical supplies. 10 Ensures site staff complete data entry and resolve queries within expected timelines. 11 Ensures accuracy, validity and completeness of data collected at trial sites 12 Proactively ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents. 13 Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management. 14 Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. 15 Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. 16 Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team. 17 Attends regularly scheduled team meetings and trainings. 18 Complies with relevant training requirements. Act as local expert in assigned protocols. Possesses proficient therapeutic knowledge sufficient to support role and responsibilities. 19 Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. Compliance Monitoring Visit (CMV). May be required to oversee audit and inspection preparation by Associate SM. 20 Prepares trial sites for close out, conduct final close out visit. 21 Tracks costs at site level and ensure payments are made, if applicable. 22 Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. 23 May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. 24 Acts as a point of contact in site management practices. Able to provide credible and useful insights and input. 25 On need basis may be assigned as a coach and mentor to a less experienced site manager. 26 May be required to contribute to process improvement and training. 27 Occasionally leads and/or participates in special initiatives as assigned. 28 May be required to assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”. This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. Principal Relationships: Primary Reporting Structure: Reports to a FM/CRM Primary interfaces: FM/CRM, CTA, LTM and TDL. Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Compliance Managers/Specialists, Training Manager, Contracts & Centralized Services (CCS), Local Safety Officer (where required) and Site Manager team. External Interfaces: Investigators and their delegates at site (trial site personnel).