clinical data management manager

Novotech

<div><p><b>About The Role:
</b></p><p>The Principal Clinical Data Manager (PCDM) is primarily responsible for providing in-depth guidance as Subject Matter Expert in Clinical Data Management (CDM) best practices, use of Electronic Data Capture (EDC) systems and other software applications that interface with EDC (e.g. IWRS, ePRO), use of eCRF standards and libraries, and creation of data listings, data visualisations and dashboards in order to undertake efficient data inspection and discrepancy (query) management.
</p><p>The PCDP will lead in developing company conventions and standards applicable to the CDM area, as well as initiatives to streamline CDM processes, in close collaboration with the Manager CDM and Manager Clinical Applications &amp; Compliance. The PCDM will mentor junior staff, develop training materials, participate in industry forums, and may undertake internal compliance assessments on request of Biometrics Management.
</p><p>The PCDM can act as Project Manager CDM looking after one client account and being the client&rsquo;s point of contact for all CDM matters regarding the client&rsquo;s clinical project(s), technically and financially. The PCDM interacts with clients, Project Managers, internal Biometrics functions and other project stakeholders within and outside of Biometrics.
</p><p><b>Minimum Qualifications &amp; Experience
</b></p><ul><li>Graduate in a clinical or life sciences related field. At least eight years of experience
</li><li>Clinical Data Management (CDM) of which 4 years working in a Senior position in the
</li><li>pharmaceutical or CRO industry.
</li><li>In-depth knowledge of all CDM related activities including use of EDC systems and other data capture applications, inspection and reconciliation of clinical and external data, and tracking and reporting on progress of CDM activities.
</li><li>Excellent understanding of regulations applicable to the CDM area as well as Good Data Management Practices, CDM and Trial Master File, and regulations regarding Electronic Data Capture (EDC) systems and validation.
</li></ul><p><b>Responsibilities:
</b></p><p><b>1.Projects/Clinical Studies
</b></p><ul><li>Participate in project meetings and client meetings as Subject Matter Expert for Clinical Data Management (CDM) providing advice on all aspects of CDM processes, systems and tools in view of client's business objectives, regulatory requirements and Novotech best practices.
</li><li>Contribute to protocol development or review client's protocol in terms of schedule of assessments, consistency with assessments&rsquo; descriptions and internal company standards of the corresponding CRFs, timing of assessments, implicit assessments (e.g. fed conditions require food intake CRF), Adverse Event definitions versus CDASH, validated questionnaires, laboratory data, etc.
</li><li>Advise other Biometrics functions, Project Management and clients with respect to the application of generic and disease specific CRF libraries and data dictionaries based on CDASH and SDTM.
</li><li><p>Support CDM staff with (complex) CDM study requirements throughout the entire study lifecycle, from protocol development to database lock and decommissioning. This includes but is not limited to:
</p><p>- Advise and peer review, as required, on the configuration. validation documentation and training requirements of non-EDC applications that need to interface with the EDC system,
</p><p>-Advise and peer review, as required, regarding the specification documents for the design of the clinical study database and additional applications (e.g. ePRO), for data reporting and visualization to facilitate data inspection, data reconciliation, clinical/medical review and CDM status reporting,
</p><p>-Advise and peer review, as required, regarding all key CDM documents for the Study Conduct, Database Lock and Decommissioning stages.<br>
</p></li></ul><p></p><ul><li><p>Undertake all Senior CDM tasks of the Start-up, Study Conduct, Database Lock and Decommissioning stages, in the role of Project CDM, and liaise with client, Project Manager, Line Manager and other stakeholders. This includes but is not limited to:
</p><p>-Establish CDM project plan and project manage all CDM deliverables across Study Start-up, Study Conduct, Database Lock and Decommissioning stages,
</p><p>-Undertake financial management of the project including monthly unit reconciliation (actualization), invoicing and forecasting,
</p><p>-Coordinate the CDM scope and impact assessment in terms of timelines and cost for change orders (change management),
</p><p>-Ensure the CDM project files and CDM project TMF are up-to-date and audit ready at any point during the study,
</p><p>-Ensure compliance with CDM SOPs and data standards over the lifecycle of the project,
</p><p>-Maintain study documentation, programs and files within project files and maintain timesheets.
</p></li></ul><p><b>2.Team
</b></p><ul><li>Participate in industry forums (conferences, professional association committee work etc.) and providing training on CDM related topics to Biometrics and wider Novotech organization. &middot; Participate in CDM team meetings and Biometrics department meetings.
</li><li>Train and mentor new and existing CDM team members in SOPs, software applications, CRF libraries, and CDM best practices &middot; Undertake internal compliance assessment upon request of Line Manager or Biometrics Management and participate in audits.
</li></ul><p><b>3.Software Tools
</b></p><ul><li>Monitor and advise Line Manager on new capabilities of EDC platforms and related clinical trial applications from a CDM perspective by participating in online user forums and attending workshops/ meetings/conferences as appropriate.
<ul><li>Develop generic and disease specific CDISC derived standards for eCRFs in collaboration with other functions within Biometrics establishing eCRF and edit check libraries for re-use across studies.
</li><li>Evaluate new CDM methodologies and practices &ndash; possibly involving new software applications &ndash; for generating efficiencies and productivity increases in CDM in consultation with the Line Manager.
</li></ul></li></ul><p><b>4.CDM Processes and SOPs
</b></p><ul><li>Lead the development and updating of SOPs and best practices, process improvement, quality control and governance related to all CDM matters.
<ul><li>Adhere to applicable regulatory guidelines and Novotech&rsquo;s corporate policies and procedures, and to SOPs, Forms, Libraries and Best Practices related to CDM.
</li>Contribute to infrastructural (non-clinical) process improvement initiatives as Subject Matter Expert for CDM.<br>
<li>
</li></ul></li></ul><p></p><p>Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
<br>
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
<br>
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.</p></div><p></p>

Principal Clinical Data Manager

Cardiovascular Research Foundation

<div><p><b>This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office.</b></p><h1 class="jobSectionHeader"><b>
SUMMARY</b></h1><p>
This position is responsible for the tasks needed to ensure timely and accurate delivery of clinical study data.</p><p><b>
SUPERVISORY RESPONSIBILITIES</b></p><p>
This position does not manage direct reports, however this position shares knowledge with other department personnel, may orient and train new personnel and may assist with the delegation of tasks and responsibilities with project work.</p><p>
 <b>ESSENTIAL DUTIES AND RESPONSIBILITIES</b></p><ul><li>
Follow the processes set forth by the department SOPs and the study Data Management Plan to ensure the highest data quality within the organizations managed databases and for outsourced EDC databases.</li><li>
Develops and maintains data management plans, CRF completion guidelines and edit check specifications.</li><li>
Develops and tests edit checks.</li><li>
Performs study data discrepancy review and generates needed queries.</li><li>
Monitors study progress as it relates to study data and generates related reports.</li><li>
Tracks outstanding data queries and facilitates timely query resolution.</li><li>
Participates in study team meetings to provide ongoing data status.</li><li>
Demonstrates knowledge of GCP/ICH regulations and 21 CFR Part 11.</li><li>
Additional duties as assigned.</li></ul><p>
 <b>QUALIFICATIONS</b></p><ul><li>
Bachelor&rsquo;s degree</li><li>
2-3 years of experience</li><li>
Experience building EDC databases in Mednet, Medidata or other systems preferred</li><li>
Basic SAS programming skills desired</li><li>
Experience with CDASH/CDISC standards preferred.</li><li>
Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment. Must be able to prioritize.</li><li>
Must be able to understand the expectations and daily workflow of the data management department.</li><li>
Willingness and flexibility to occasionally work evenings and weekends to support needs of the Department Manager.</li><li>
Ability to effectively communicate verbally with CRF employees and outside vendors as required.
</li><li>Ability to communicate effectively when reading and writing e-mail, memos and presentations on behalf of the Department Manager.</li><li>
Ability to analyze information and solve problems.</li></ul><p><b>
BENEFITS</b></p><ul><li>
Choice of health plans include medical, Dental, and vision coverage</li><li>
Company-paid short-term and long-term disability and life insurance</li><li>
Health and dependent care flexible spending accounts</li><li>
Pre-tax travel expenses through TransitChek program</li><li>
401(k) plan</li><li>
Generous paid time off (PTO)</li><li>
Ten paid holidays each year</li></ul><p><b>
COMPENSATION</b></p><p>
The hiring range for this position is $80,000 - $110,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience.</p><p><b>
CONTACT INFORMATION</b></p><p>
To be considered for this opportunity, please submit your resume.</p><p>
Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day www.crf.org</p><p><b><i>
CRF is an equal opportunity employer.</i></b></p><p>
#LI-LS1</p></div>

Clinical Data Manager

Hartford HealthCare

<div><p><b>Location Detail: </b>100 Pearl Street Hartford (10484)</p><p><b>
Shift Detail: </b>Monday-Friday</p><p>
Work where every <b>moment </b>matters.</p><p>
</p><p>Every day, more than 40,000 Hartford HealthCare colleagues come to work with one thing in common: Pride in what we do, knowing every moment matters here. We invite you to become part of Connecticut&rsquo;s most comprehensive healthcare network.</p><p><br>
The Clinical Risk Management Data Analyst is responsible for performing data analysis and project management activities including collecting raw data from Riskonnect, EPIC, and other sources; analyzing and interpreting clinical risk data; preparing the data in meaningful format; identifying areas for risk prevention and risk mitigation; and managing various projects supporting the work of Clinical Risk Management. Responsibilities include but, are not limited to the following:</p><ul><li> Performs comprehensive and accurate clinical risk data analysis and interpretation to support senior level decision-making regarding clinical risks and mitigation opportunities, including risk assessment activities.</li><li> Collaborates with others in risk management, members of leadership, and other stakeholders to analyze and understand data and develop risk prevention, mitigation, and improvement initiatives, as appropriate.</li><li> Creates system-level and other reports, while ensuring data quality and integrity, to assist in identifying organizational risk priorities.</li><li> Drafts reports to senior management of risk operations/progress, data, KRIs, metrics, and efforts.</li><li> Monitors patient, visitor, and staff incidents for trends; analyzes data to identify areas of potential liability.</li><li> Collaborates with leadership, IT, and others in Risk Management to design, build, evaluate, monitor, and improve Risk Management, Claims, PCE, Regulatory, and other relevant tiles and workflows within Riskonnect to maximize efficiency, follow-up, and data collection and analysis.</li><li> Provides data-driven insights to support risk assessments, risk prevention, risk mitigation, and strategic planning.</li><li> Provides consultative support for analysis and interpretation of clinical risk and patient safety event data for system, regional and institute leaders across the system to identify areas of risk.</li><li> Supports the identification of root causes, as appropriate, of adverse events, near misses, and claims for risk prevention and risk mitigation activities.</li><li> Develops dashboards and scorecards to monitor key risk indicators (KRIs) and clinical risk metrics.</li><li> Supports the tracking of Incident Response Team and CARe case data to qualify and quantify activity across the system.</li><li> Supports data-driven decision making for risk mitigation and continuous improvement.</li><li> Serves as a consultant in the evaluation and analysis of current Clinical Risk Management and processes and assists in identifying and implementing innovative solutions to reduce gaps and minimize waste in the process.</li><li> Provides logistical planning for risk management educational programs, as appropriate.</li><li> Assists with the identification, conduction, and evaluation of risk management educational programs.</li><li> Drafts reports, educational materials, and other documents, as appropriate and in collaboration with leadership, to support the work of Clinical Risk Management</li><li> Assists with the analysis of risk assessment findings and survey results for developing recommendations, strategies, and action plans for improvement opportunities to mitigate risk potential.</li><li> Assists with the follow-up on corrective action plans for resolution of problematic system or process issues.</li><li> Leads, co-leads, or collaborates, as appropriate, on clinical risk management projects to support clinical risk management operations and the systemwide clinical risk work.</li></ul><h3 class="jobSectionHeader"><b><br>
Qualifications</b></h3><br>
<p><b>
Education:</b></p><ul><li> Bachelor&rsquo;s Degree in Health Administration, Management, Data Science, Statistics, or related discipline preferred</li></ul><p><b>
Experience:</b></p><ul><li> 3 years of recent healthcare data analysis and project management experience.</li><li> Demonstrated experience with healthcare data analytics, project management, and meaningful data presentation.</li><li> Demonstrated service excellence and customer service orientation.</li></ul><p>
We take great care of careers.</p><p><br>
With locations around the state, Hartford HealthCare offers exciting opportunities for career development and growth. Here, you are part of an organization on the cutting edge &ndash; helping to bring new technologies, breakthrough treatments and community education to countless men, women and children. We know that a thriving organization starts with thriving employees- we provide a competitive benefits program designed to ensure work/life balance. Every moment matters. And this is <b>your moment.</b></p></div>

Clinical Risk Management Data Analyst

Precision Medicine Group

<p></p><div><p><b>Position Summary:</b></p>
<ul>
<li>The FSP Manager Global Clinical Monitoring (GCM) offers an additional development path for clinical research professionals. Responsibilities are focused on the management and career development of the organization's Clinical Research Associate (CRA) workforce as well as providing oversight and coordination of project activities for CRAs assigned to FSP partnership.</li>
<li>This position requires the ability to independently lead, manage, and motivate a team of CRAs to a standard consistent with Precision for Medicine's values and overall focus on quality. In addition, this position will provide the CRAs with career development and support, to minimize turnover and maintain high levels of employee satisfaction.</li>
</ul>
<p><b>Essential functions of the job include but are not limited to:</b></p>
<ul>
<li>Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals.</li>
<li>Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within the FSP work order. Update tracking systems and interface with project teams.</li>
<li>Collaborate with the FSP Oversight Director and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.</li>
<li>Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.</li>
<li>Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues.</li>
<li>Identify quality risks and issues and recommend corrective action plans as needed to address deficiencies in performance of employees.</li>
<li>Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.</li>
<li>Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&amp;E, etc.) on company systems.</li>
<li>Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution.</li>
<li>Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics.</li>
<li>Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process.</li>
<li>Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training, and other functional areas, including sponsor specific training requirements.</li>
<li>Represent Precision for Medicine in a professional manner.</li>
<li>Manage CRA staff in accordance with Precision for Medicine's values and policies.</li>
<li>Review and approve all visit reports, timecards, and expense reports for assigned CRAs.</li>
<li>Ensure monitoring visits are performed in accordance with monitoring plan.</li>
<li>Provide oversight of CRA project performance including eTMF completion and quality, SDV completion, and query/issue closure timeliness.</li>
<li>Attend investigator meetings and regular internal / sponsor meetings to discuss study progress and team performance.</li>
<li>Provide oversight of Study Start-up Team to ensure sites progress from selection to initiation visit on-time and in agreement with sponsor expectations.</li>
<li>Support CRAs and Study Start-up with ICF customization and version tracking.</li>
<li>Ensure study systems and trackers are kept up to date.</li>
<li>Planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.</li>
<li>Perform other duties as assigned by Leadership.</li>
</ul>
<p><b>Qualifications:</b><br>
Minimum Required:</p>
<ul>
<li>Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline</li>
</ul>
<p>Other Required:</p>
<ul>
<li>At least 7 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience.</li>
<li>Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.</li>
</ul>
<p>Preferred:</p>
<ul>
<li>Experience in the Therapeutic area/country of the staff assigned to manage.</li>
</ul>
<p><b>Skills/Competencies:</b></p>
<ul>
<li>Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.</li>
<li>High capacity for Emotional Intelligence and a passion for people management and development.</li>
<li>As part of overall line management responsibilities, ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs.</li>
<li>Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution related problems at the site level.</li>
<li>Demonstrates understanding and ability to work with EMRs and EDCs</li>
<li>Exhibits high self-motivation and can work and plan independently as well as in a team environment.</li>
<li>Motivates other members of the project team to meet timelines and project goals.</li>
<li>Highly organized, ability to set priorities and possesses excellent problem-solving skills.</li>
<li>Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.</li>
<li>Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.</li>
<li>Ability to develop, coach and mentor CRA staff.</li>
<li>Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.</li>
<li>Communicates both verbally and in written form in an acceptable manner.</li>
<li>Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.</li>
<li>Possesses practical knowledge of IT tools and systems in use on project teams.</li>
<li>Values system and work ethic consistent with Precision Values and Company Principles</li></ul><br>
<p></p>
<p></p><div>
<p>Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.</p>
<p>
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.</p>
<p>
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.</p>
<p>
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</p></div></div><p></p>

FSP Manager, Global Clinical Monitoring

Devoted Health

<div></div><div><div>Job Description</div><div><i>
A bit about this role:</i></div><div>
We can&rsquo;t transform health care for America&rsquo;s seniors alone. It requires coordination and information exchange within the healthcare supply chain. If we do it well, we believe we can improve how healthcare is paid for, delivered, and experienced.</div><div>
Having member clinical data is critical for understanding member healthcare needs to drive their health outcomes. The Clinical Data Acquisition Team ensures that clinical data is available at the right place and the right time for the Devoted teams.</div><div></div><div><i>
Your Responsibilities and Impact will include:</i></div><ul><li><div>
Develop deep understanding of the clinical data needs (e.g. medical records, lab results, ADT, etc.) and data usability requirements across Devoted Health Plans and Devoted Medical.</div></li><li><div>
Collaborate with and align on outcomes with stakeholders across a variety of teams including Network Management, Risk Adjustment, Stars, Devoted Medical, Payment Integrity, and others.</div></li><li><div>
Analyze clinical data availability across geographical areas to develop insights about data gaps, the reasons data is not available, and opportunities to obtain data.</div></li><li><div>
Using data insights, define an execution plan to ensure the broadest coverage of clinical data in the markets and ensure clinical data is usable by stakeholder teams.</div></li><li><div>
Implement technical integrations with Health Information Exchanges (HIEs), Labs, Electronic Health Record (EHR) systems, and other sources of clinical data and ensure quality of data received.</div></li><li><div>
Understand industry dynamics in order to consistently consider and vet new vendors or services that might improve our efficiency in obtaining and utilizing key clinical data.</div></li><li><div>
Explore and apply new processes and methodologies using AI to ensure clinical data is consistently available and usable by key stakeholders.</div></li><li><div>
Define, implement, and drive appropriate KPIs to measure success.</div></li></ul><div><i><br>
Required skills and experience:</i></div><ul><li><div>
5+ years of healthcare related and/or program management professional experience</div></li><li><div>
Understanding of healthcare IT systems, and methods/standards of healthcare data exchanges (e.g. SFTP, FHIR, API, HL7, XML, etc)</div></li><li><div>
Proven ability to analyze complex data sets, derive insights, and develop an execution plan based on the data.</div></li><li><div>
Proficiency in performing data analysis and reporting using SQL queries and Google Sheets. Experience with Looker is a plus.</div></li><li><div>
Excellent communication skills and a track record of working cross-functionally with a variety of teams including Operations, Network Management, Product, and Technology, as well as external partners.</div></li><li><div>
Ability to effectively manage multiple priorities, critical tasks, and conflicting requirements in a fast-paced environment.</div></li><li><div>
Results-oriented with the proven ability to review processes, identify opportunities, and work independently, driving projects to completion.</div></li><li><div>
Ability to incorporate company vision, mission, and values in decision making</div></li></ul><div></div><div>
#LI-Remote<br>
<br>
Salary range: $80,000-$135,000 / year</div><div></div><div><br>
The pay range listed for this position is the range the organization reasonably and in good faith expects to pay for this position at the time of the posting. Once the interview process begins, your talent partner will provide additional information on the compensation for the role, along with additional information on our total rewards package. The actual base salary offered will depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.</div><div></div><div>
Our Total Rewards package includes:</div><ul><li><div>
Employer sponsored health, dental and vision plan with low or no premium</div></li><li><div>
Generous paid time off</div></li><li><div>
$100 monthly mobile or internet stipend</div></li><li><div>
Stock options for all employees</div></li><li><div>
Bonus eligibility for all roles excluding Director and above; Commission eligibility for Sales roles</div></li><li><div>
Parental leave program</div></li><li><div>
401K program</div></li><li><div>
And more....</div></li></ul><div></div><ul><li><i>Our total rewards package is for full time employees only. Intern and Contract positions are not eligible.</i></li></ul><div></div><div>
Healthcare equality is at the center of Devoted&rsquo;s mission to treat our members like family. We are committed to a diverse and vibrant workforce.</div><div></div><div>
At Devoted Health, we&rsquo;re on a mission to dramatically improve the health and well-being of older Americans by caring for every person like family. That&rsquo;s why we&rsquo;re gathering smart, diverse, and big-hearted people to create a new kind of all-in-one healthcare company &mdash; one that combines compassion, health insurance, clinical care, service, and technology - to deliver a complete and integrated healthcare solution that delivers high quality care that everyone would want for someone they love. Founded in 2017, we've grown fast and now serve members across the United States. And we've just started. So join us on this mission!</div><div></div><div>
Devoted is an equal opportunity employer. We are committed to a safe and supportive work environment in which all employees have the opportunity to participate and contribute to the success of the business. We value diversity and collaboration. Individuals are respected for their skills, experience, and unique perspectives. This commitment is embodied in Devoted&rsquo;s Code of Conduct, our company values and the way we do business.</div><div></div><div>
As an Equal Opportunity Employer, the Company does not discriminate on the basis of race, color, religion, sex, pregnancy status, marital status, national origin, disability, age, sexual orientation, veteran status, genetic information, gender identity, gender expression, or any other factor prohibited by law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.</div></div>
<br><p></p><div><div><div><div><div><div>We have been made aware of instances of fraudulent job postings and/or fraudulent recruiting activity by individuals purporting to represent Devoted Health. These fraudulent schemes often seek monetary contributions or payments from job seekers (such as for &ldquo;start up costs&rdquo; or &ldquo;equipment&rdquo;), or seek to collect sensitive personal information. These job postings and offers are NOT authorized by Devoted Health and Devoted is not responsible for fraudulent offers, personal information that you may have disclosed, or payments made to third parties purporting to represent Devoted. We have reported this matter and are cooperating with law enforcement agencies. Devoted Health will never ask for financial commitment or contribution from a candidate at any stage of the recruitment process.</div></div></div></div></div></div><div></div>

Manager, Clinical Data Acquisition

Dr. Hüttner Personalberatung

"Hier ist anders" ist Motto und gleichzeitig Anspruch unseres Klinikums. Das Klinikum Esslingen ist ein Krankenhaus der Zentralversorgung, das von und durch die Vielfalt seiner Mitarbeitenden lebt, auf moderne Medizin und kollegiale Atmosphäre besonderen Wert legt und tief mit der Stadt Esslingen am Neckar und seinen Menschen verwurzelt ist.<br> Der Geschäftsbereich Medizincontrolling und . klicken sie bewerben, für die volle Stellenbeschreibung

Geschäftsbereichsleiter (m/w/d) Für Das Medizincontrolling Und Patientenmanagement

Allucent

<div><p>The Project Data Manager (PDM) leads and oversees data management activities, timelines and finances of the Allucent Data Management (DM) department.
</p><p>This position manages and coordinates DM deliverables from database design &amp; set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.
</p><p>This position acts as a Project Manager and is responsible for the overall coordination and management of Data Management/Biostats standalone projects, large and complex trials and/or multiple projects belonging to one client.
</p><p>This position oversees day-to-day operations and coordinates planning and operational activities of assigned junior team members, like, CDM1, CDM2 and CDM3 and their assigned projects.
</p><p>The PDM is a member of the Data Management staff.</p><p><b>
Requirements</b></p><ul><li>Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Biostatistics and if applicable other functional groups, such as Project Management, Clinical Operations) and externally (e.g. sponsors, vendors (EDC, external data), investigational sites)</li></ul><p></p><p><br>
As a Project Manager for Biometrics stand-alone studies, the Project Data Manager will:<br>
<br>
</p><ul><li>Lead and coordinate the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract</li><li>Create and execute project management plans required for project delivery and in accordance with established processes</li><li>Establish requirements for and ensure project-specific training plan for internal team members</li><li>Establish clear communication lines and escalation pathways, communicate with project stakeholders, both internally (e.g. Clinical Programmers, Data Scientists, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data) and other external parties)
</li><li>Establish requirements for and ensures project-specific training plan for internal team members</li></ul><p>
</p><ul><li>Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Biostatistics and if applicable other functional groups, such as Project Management, Clinical Operations) and externally (e.g. sponsors, vendors (EDC, external data), investigational sites)</li></ul><p></p><p><br>
</p><p></p><p>As a Project Manager for Biometrics stand-alone studies, the Project Data Manager will:<br>
<br>
</p><p></p><ul><li>Lead and coordinate the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract</li></ul><p>
</p><ul><li>Create and execute project management plans required for project delivery and in accordance with established processes</li></ul><p>
</p><ul><li>Establish requirements for and ensure project-specific training plan for internal team members</li></ul><p>
</p><ul><li>Establish clear communication lines and escalation pathways, communicate with project stakeholders, both internally (e.g. Clinical Programmers, Data Scientists, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data) and other external parties)
</li></ul><p></p><ul><li>Establish requirements for and ensures project-specific training plan for internal team members</li></ul><p>
</p><ul><li>Establish project risk management plan with input from client and functional stakeholders and oversee adherence and updates throughout the project lifecycle</li></ul><p>
</p><ul><li>Lead internal meetings with internal team members and external meetings with a sponsor, and third party (data) vendors, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope</li></ul><p>
</p><ul><li>Provide support for vendor identification, qualification and selection and manage vendors</li></ul><p>
</p><ul><li>Manage vendors and vendor relationships as required for project delivery</li></ul><p>
</p><ul><li>Arrange, maintain and circulate project progress and status reports</li></ul><p></p><p><br>
</p><p></p><p>In addition, as a Project Manager for Biometrics stand-alone studies and/or large, complex or multiple studies with same client, the Project Data Manager will:<br>
<br>
</p><p></p><ul><li>Lead the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract</li></ul><p>
</p><ul><li>Ensure overall consistency across all client studies within a set of projects; this especially relates to the DM activities; Data Management Plan (DMP), CRF design, data cleaning and query management) and for Biometrics stand-alone projects also include statistical deliverables (SAP, TLFs)</li></ul><p>
</p><ul><li>Lead internal meetings with internal project team members. Support and participate in external meetings with a sponsor, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope</li></ul><p>
</p><ul><li>Interact, negotiate and influence internal and external team members in a professional manner and with successful outcomes</li></ul><p>
</p><ul><li>Ensure effective and efficient resource utilization across projects and programs</li></ul><p>
</p><ul><li>Manage the study budget, evaluate financial project health and manage monthly status updates for invoicing. Participate in monthly project review meetings</li></ul><p>
</p><ul><li>Proactively recognize and address any changes in scope. Liaise to execute contract amendments</li></ul><p>
</p><ul><li>Oversee Sponsor relationships</li></ul><p>
</p><ul><li>Assist in contracts negotiation and contracting process with vendors (EDC, IRT)
</li></ul><p></p><ul><li>May support operational Data Management activities, also to ensure and assess quality</li></ul><p>
</p><ul><li>Oversee and ensure the Trial Master File for DM services in scope is kept up to date and audit/inspection ready.</li></ul><p>
</p><ul><li>Contribute to other areas of business as required</li></ul><p>
</p><ul><li>Research, propose and lead initiatives for improving efficiency</li><li>Manage direct reporting staff, perform performance reviews and support team member personal development plans</li><li>Oversee and supervise work done by junior team members (CDM1 level &ndash; CDM3 level)</li><li>Actively support to staff learning &amp; development within the company</li><li>Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions</li><li>Represent the company through active participation at professional meetings, webinars or seminars</li><li>Provide and coordinate Data Management training for relevant staff. Support in development of new training material
</li><li>Train and mentor data management staff, support in development of new training material and provide training to relevant staff</li><li>Participate in the interview process for new recruits</li><li>Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Senior Directors, for further alignment and improvement of current processes</li></ul><p>
</p><p>Quality Management</p><p>
</p><ul><li>Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System</li></ul><p></p><p><br>
</p><p></p><p>Account Management, Sales &amp; Acquisition</p><p>
</p><ul><li>Assure good communication and relationships with (future) clients</li></ul><p>
</p><ul><li>Contribute to and take part in client evaluations and visits</li></ul><p>
</p><ul><li>Support in preparation of new proposals and budgets for Data Management services</li></ul><p>
</p><ul><li>Support Business Development (BD) in preparing and providing presentations to potential and existing clients through attendance at capabilities and/or bid defense meetings</li></ul><p>
</p><ul><li>Provide input into tools and templates to support costing and bidding</li></ul><p></p><p><br>
</p><p></p><p>Others</p><p>
</p><ul><li>Contribute to other areas of business as required</li></ul><p>
</p><ul><li>10% Travel</li></ul><p>
</p><p><b>Education Requirements and Qualifications</b></p><p>
</p><p>Qualifications
</p><p></p><ul><li>Life science, healthcare degree and/or combination of education and experience</li></ul><p>
</p><ul><li>Minimum 8 years of relevant work experience in Clinical Data Management or related experience within Biometrics
</li></ul><p></p><ul><li>Minimum 8 years of relevant experience in related clinical trials environment</li></ul><p>
</p><ul><li>Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements</li></ul><p>
</p><ul><li>Good understanding of Medical Terminology</li></ul><p>
</p><ul><li>Experience as DM Lead on several studies and experience in covering all phases of a clinical study (start up, conduct and database lock). Worked on multiple indications and clinical phases (I-IV)</li></ul><p>
</p><ul><li>Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation</li></ul><p>
</p><ul><li>Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models</li></ul><p>
</p><ul><li>Client management experience</li></ul><p>
</p><ul><li>Experience in developing data management standards</li></ul><p>
</p><p>Skills</p><p>
</p><ul><li>Strong written and verbal communication skills including good command of English language
</li></ul><p></p><ul><li>Representative, outgoing and client focused
</li></ul><p></p><ul><li>Ability to work in a fast-paced challenging environment of a growing company</li></ul><p>
</p><ul><li>Proficiency with various computer applications such as Word, Excel, and PowerPoint required</li></ul><p>
</p><ul><li>Administrative excellence
</li></ul><p></p><ul><li>Attention to detail, strong technical, analytical and problem-solving skills</li></ul><p>
</p><ul><li>Strong project management skills</li></ul><p>
</p><ul><li>Ability to translate guidelines, rules and regulations in clear and usable recommendations</li></ul><p>
</p><ul><li>Ability to simplify complex issues into understandable concepts</li></ul><p>
</p><ul><li>Excellent organizational, negotiating and motivational skills</li></ul><p></p><p><br>
</p><p></p><p><b>Benefits</b></p><p><b>
Benefits of working at Allucent include:</b></p><ul>
<li>Comprehensive benefits package per location</li>
<li>Competitive salaries per location
</li><li>Departmental Study/Training Budget for furthering professional development
</li><li>Flexible Working hours (within reason)
</li><li>Leadership and mentoring opportunities
</li><li>Participation in our enriching Buddy Program as a new or existing employee</li>
<li>Internal growth opportunities and career progression
</li><li>Financially rewarding internal employee referral program
</li><li>Access to online soft-skills and technical training via GoodHabitz and internal platforms</li>
<li>Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
</li><li>Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees</li>
</ul><p></p><p><b>Disclaimers:</b></p><p>
</p><p><i>&ldquo;The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively &ldquo;Allucent&rdquo;). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.&rdquo;</i></p></div>

Project Data Manager

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