senior clinical data manager

ICON plc

<div>Manager Clinical Data Science, Trivandrum, India<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Manager, Clinical Data Science to join our diverse and dynamic team. As a Manager, Clinical Data Science at ICON, you will play a pivotal role in overseeing the analysis and interpretation of clinical data to support drug development and improve patient outcomes. You will contribute to the advancement of innovative treatments through strategic leadership in data management and analytics, ensuring the highest standards of quality and compliance in clinical research.</div><div>
What You Will Be Doing:</div><div></div><ul><li>
Driving the analysis of clinical trial data to derive actionable insights and support decision-making processes.</li><li>
Collaborating with cross-functional teams to ensure effective data collection, management, and reporting throughout clinical trials.</li><li>
Overseeing the implementation of best practices in data science methodologies and technologies within the organization.</li><li>
Providing mentorship and guidance to junior data scientists, fostering a culture of continuous improvement.</li><li>
Establishing strong partnerships with internal and external stakeholders to enhance data integrity and optimize clinical outcomes.</li></ul><div>
Your Profile:</div><div></div><ul><li>
Advanced degree in a relevant field such as biostatistics, data science, or a related discipline.</li><li>
Extensive experience in clinical data analysis, with a solid understanding of regulatory requirements and industry standards.</li><li>
Strong leadership skills with the ability to inspire and manage teams effectively in a collaborative environment.</li><li>
Proficiency in statistical software and programming languages, with a keen ability to translate complex data into clear insights.</li><li>
Excellent communication and interpersonal skills, with a track record of influencing stakeholders and driving positive change.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Manager Clinical Data Science

Exelo Technologies Inc

<ul><li>Lead CDM activities for assigned clinical studies, ensuring data quality and compliance with study timelines.</li><li>Design and/or support the design of clinical databases in alignment with study protocols and requirements, including creation of edit checks and dynamic functionalities.</li><li>Conduct User Acceptance Testing (UAT) to validate clinical database functionality and accuracy.</li><li>Author, review, and approve study-specific CDM documentation such as Data Management Plans (DMPs), Case Report Form Completion Guidelines (CCGs), Data Transfer Agreements (DTAs), and EDC specifications.</li><li>Support data cleaning and validation activities to ensure completeness and accuracy of study data.</li><li>Monitor study progress to ensure milestones are met and deliverables are achieved on schedule.</li><li>Oversee and manage CDM vendors to ensure high-quality deliverables and adherence to project timelines.</li><li>Ensure all CDM operations comply with applicable Standard Operating Procedures (SOPs) and regulatory guidelines.</li><li>Identify and communicate potential risks or challenges to the Head of CDM and Clinical Project Manager (CPM), and collaborate with the study team to develop and implement risk mitigation strategies.</li><li>Ensure timely and accurate filing of CDM documentation in the Trial Master File (TMF).</li><li>Supervise and provide guidance to junior CDM staff on assigned studies.</li><li>Perform additional CDM-related duties as required.</li></ul><p><b>Qualification Requirements:</b></p><ul><li>Bachelor&rsquo;s degree in a health-related, scientific, or equivalent field.</li><li>5&ndash;8 years of experience in Clinical Data Management role.</li><li>Strong understanding of Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and CDM processes.</li><li>Hands-on experience with multiple Electronic Data Capture (EDC) systems.</li><li>Familiarity with additional CDM tools and analytics platforms preferred.</li><li>Advanced proficiency in Microsoft Excel (formulas, pivot tables); basic knowledge of SAS or other programming languages is an advantage.</li><li>Proficient in Microsoft Office Suite, Microsoft Teams, and SharePoint.</li><li>Excellent written and verbal communication skills.</li><li>Strong organizational skills with keen attention to detail.</li><li>Proven ability to prioritize, manage multiple tasks, and meet deadlines effectively.</li></ul><p>Job Types: Full-time, Contract</p><p>Pay: $75,000.00 - $100,000.00 per year</p><p>Work Location: Remote</p>

Clinical Data Manager

Syneos Health

<div><p><b>Description</b>
</p>Senior Clinical Programmer (Veeva CDB)<p></p><p>
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.</p><p>
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.</p><p></p><p>
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.</p><p></p><p>
Discover what our 29,000 employees, across 110 countries already know:</p><p></p><p><b>
WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>
Why Syneos Health</p><ul><li>
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.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
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 &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul><p></p><p><b>
Job Responsibilities</b></p><p></p><ul><li>
Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.<br>
Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports..</li><li>
Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.</li><li>
Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports</li><li>
Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions.</li><li>
Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with inprogress audits.</li><li>
Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders.</li><li>
Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed.</li><li>
Performs system integration activities, application updates, and user acceptance testing.</li><li>
Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs.</li><li>
Assists in project meetings and actively contributes and participates in departmental review meetings. Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies.</li><li>
Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements.</li><li>
Manages project resources, proactively alerting management of delivery and resourcing needs.</li><li>
Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.</li></ul><p></p><p>
Qualifications:</p><p></p><ul><li>
Bachelor&rsquo;s degree preferred, or equivalent combination of related education and experience.</li><li><b>
Looking for Veeva CDB (Clinical Database) resource at Senior / Principal Role.</b></li><li><b>
This resource would be within Administration for Veeva as an SME.</b></li><li><b>
Veeva CDB is additional Data acquisition model, so a person should have strong Data Acquisition experience with technical expertise in Veeva CDB, working with External Vendor, experience with Data Transfer Agreements (DTA), Data Import Agreements, Data Mapping, and having SAS experience would be added advantage.</b></li><li><b>
Veeva CDB is an exclusive model used for report generation and analytics outcome from EDC.</b></li><li><b>
Alternate to CDB Programmer is that we look for base experience in EDC programming willing to move into this role as CDB programmer, have exposure to CDB/Data Acquisition.</b></li><li><b>
Must be strong in communication, experience in mentoring, have strong data acquisition experience into CDB</b></li><li><b>
Required years of experience &ndash; 2 years in CDB or Overall 5+ years of Data Acquisition, Data Import, Program writing, DTA, DTS experience.</b></li><li>
Ability to deal effectively with sponsors and internal customers at all levels.</li><li>
Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.</li><li>
Demonstrated experience in managing multiple priorities in a highly dynamic environment</li><li>
Experience working in a matrix-structured environment is preferred</li><li>
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail</li><li>
Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred.</li><li>
Ability to travel as necessary (up to 25%)</li></ul><p></p><p><b>
Get to know Syneos Health</b></p><p><br>
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.</p><p></p><p>
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.</p><p></p><p>
http://www.syneoshealth.com</p><p></p><p><b>
Additional Information</b></p><p><br>
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.</p><p><b>
Summary</b>
</p>Roles within Clinical Programming job family are responsible for developing programs and providing statistical programming support for statisticians or for client or business use to address needs for sourcing, organizing (creating statistical tables, listings, and graphs), and interpreting complex data sets utilizing codes and programs. This includes developing codes that create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions geared toward increasing productivity.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.</div>

Senior Clinical Programmer (Veeva CDB)

Avint

<div><p>Avint, LLC is seeking a dedicated and motivated <b>Senior Configuration Data Manager </b>to join our team. This role will provide configuration support and management in accordance with the program&rsquo;s Configuration Management Plan, Air Force SEAM Configuration Management processes, program development/sustainment contracts, and PMO practices.</p><p></p><p><b><i><br>
**This position is 100% on-site at Hanscom AFB, MA**</i></b></p><p><b>
Requirements</b></p><ul>
<li>
Must be a U.S. Citizen</li>
<li>Active Top Secret Security Clearance with SCI eligibility</li>
<li>Experience in MS Office Suite software</li>
</ul><p><b>
Responsibilities</b></p><ul>
<li>
Manage configuration of software, engineering documents, design drawings, engineering changes and notices, and planning/conducting design audits.</li>
<li>Provide CM of all relevant program artifacts.</li>
<li>Archive acquisition documentation.</li>
<li>Maintain CM files including configuration identification, change control, and status accounting records.</li>
<li>Convene and manage the Configuration Control Boards (CCBs), Technical Review Boards (TRBs), and record approved changes and results.</li>
<li>Participate in cross-functional change control boards to evaluate proposed changes.</li>
<li>Review and analyze proposed changes to ensure operational and sustainment capabilities are not adversely affected by the changes.</li>
<li>Review the CCB membership list for currency and completeness.</li>
<li>Report the Development/Sustainment&rsquo;s data delivery status.</li>
<li>Review and analyze the development/sustainment Contractor&rsquo;s conformance to CDRL requirements.</li>
<li>Process Government and development/sustainment Contractor correspondence. Ensure compliance with DoDI 5230.24, DODD 5230.25, DoD 5010.12-M. DoD 5000.02-R, DFARS 252.227-7013, DFARS 252.227-7014, and ASSIST database. Perform other duties as assigned</li>
</ul><p><b>
Desired Qualifications:</b></p><ul>
<li>
IT Configuration Management experience within the Department of Defense environment</li>
<li>Experience performing HW and SW configuration audits</li>
<li>Experience performing the technical/administrative activities necessary to manage CM tools for inventory control, version control, data duplication, and media labeling</li>
<li>Experience producing release notes and CM reports</li>
<li>An in-depth understanding of the configuration change control process, the role of the Change Control Board, and change control documentation</li>
<li>Experience performing baseline administrative activities for multiple environments</li>
<li>Experience developing briefings for management</li>
<li>Understanding of all phases of the software development life cycle</li>
<li>Ability to enter and manipulate data in a database</li>
<li>Strong attention to detail</li>
<li>Strong organizational skills and the ability to multi-task</li>
<li>Ability to work independently and with a team</li>
</ul><p><b>
Benefits</b></p><p>
Joining Avint is a win-win proposition! You will feel the personal touch of a small business and receive BIG business benefits, from competitive salaries, full health insurance, generous time off, and observation of federal holidays. Additionally, we encourage every Avint employee to further their professional development. To assist you in achieving your goals, we offer reimbursement for courses, exams, and tuition. Interested in a class, conference, program, or degree? Avint will invest in YOU and your professional development! Salary Range $115,000-$125,000</p></div>

Senior Configuration Data Manager

DUBAI PROPERTIES GROUP LLC

<p>• Assist in preparing and monitoring the department’s annual budget to support effective financial planning and departmental operations.</p><p>• Perform basic financial analysis to help identify spending patterns and support cost-effective decision-making.</p><p>• Prepare and upload purchase requisitions, Goods Receipt Notes (GRNs), and invoices to ensure accurate and timely processing in compliance with company policies and procedures.</p><p>• Support adherence to internal financial policies and accounting guidelines to maintain accuracy and compliance in financial transactions.</p><p>• Maintain and organize departmental records—including reports, documents, correspondences, and employee files—for easy access and proper documentation.</p><p>• Help implement and maintain data management tools and processes to support accurate and organized information storage.</p><p>• Coordinate internal communications between Admin, Services, and Facilities teams to ensure smooth information flow and operational support.</p><p>• Compile and assist in preparing reports, dashboards, and presentations for review by senior team members or management. Ensure regular reporting is completed accurately and submitted on time in line with department goals.</p><p>• Support with the preparation of recommendations by gathering relevant data and contributing to team discussions.</p><p>• Assist in collecting and organizing sustainability data to support reporting requirements and compliance needs.</p><p>• Support the improvement of daily workflows and processes to help increase team efficiency and output.</p>

Senior Executive - Records and Data

inoptra Digital

<p><b>Director / Sr. Director / Manager&ndash; ADMS (+ Data &amp; AI) </b></p><p>Domain (End-Clients): Telecom, Manufacturing, Oil &amp; Gas, BFSI or Healthcare</p><p><b>The position reports to the CEO.</b></p><p><b>About the Role:</b></p><p>We are looking for a strategic and hands-on Practice Head / Director: ADMS to lead <b>our Application Development &amp; Maintenance Services and Digital (ADMS) vertical</b>. The ideal candidate brings 18&ndash;24 years of deep technology, client engagement, and delivery experience across Telecom, Oil &amp; Gas, and Manufacturing, with a strong technical foundation in Java, Python, Cloud (AWS/Azure/GCP), SQL, Data, and AI/ML.</p><p>This leadership role combines delivery excellence, presales ownership, and practice growth, ideally suited for professionals who have worked in fast-paced, startup-like, or transformation-focused environments. Experience of working for international end-clients is a must. Travel or working experience in the USA, Europe, or Japan is an additional advantage.</p><p>As the position reports to the CEO, he/she is expected to own up the development of ADMS practice to a large practice over the next 2 to 3 years with P&amp;L responsibility: including Team hiring, Talent development, L&amp;D, Annual appraisals, Client development (along with sales) and winning new clients (along with sales). He/ she must be strategic but highly implementation / result-oriented. He must be able to drive the practice under the direction of the CEO and with the strategies aligned with the organization's goals, values, and culture.</p><p><b>Key Responsibilities:</b></p><p>Technology Leadership:</p><ul><li>Strong technical depth in the latest Digital Technologies: Python, Java, and various Full-Stack technologies, Data, and Cloud technologies.</li><li>Strong experience in handling Agile Product Developments/projects for international clients.</li><li>Strong Expertise in Contemporary Digital Technologies and Practices</li><li>Good expertise in the latest IT developmental practices (Agile, CI/CD, DevOps, SRE, AI/ML)</li></ul><p>Delivery Leadership:</p><ul><li>End-to-end ownership of complex global ADMS engagements.</li><li>Manage large cross-functional teams across geographies (onsite/offshore).</li><li>Ensure SLA adherence, quality, and business outcomes.</li><li>Good working knowledge of project estimation techniques.</li><li>Solid experience in using Agile practices. Expertise with Atlassian JIRA, Confluence, and Gantt charts.</li></ul><p>Practice Development:</p><ul><li>Build and scale ADMS capabilities including full-stack, cloud-native, and data-driven application development.</li><li>Upskill team members in modern technologies: Java, Python, SQL, Cloud platforms, and analytics.</li><li>Define best practices, reusable frameworks, and accelerators for ADMS delivery.</li><li>Establish and continually improve the delivery processes, client communications, reports, and governance for client engagements.</li></ul><p>Key Requirements:</p><ul><li>Around 20 years of progressive IT experience in ADMS: moved up from hands-on development to Lead roles to leadership roles.</li><li>Deep domain knowledge in Telecom, Oil &amp; Gas, Manufacturing, Technology, E-Commerce and/or BFSI.</li><li>Strong technical background:</li><li>Languages: Python, Java, Django (&amp; other Fullstack technologies)</li><li>Cloud Platforms: AWS / Azure / GCP</li><li>Databases &amp; SQL</li><li>Analytics &amp; Reporting: Basic to intermediate understanding of data pipelines, reporting tools, and dashboards.</li><li>Experience leading presales, solutions, and proposals.</li><li>Track record of managing large delivery teams across multiple clients, geographies and technology stacks</li><li>High Energy and motivation.</li><li>Ambition to grow from mid-management to top-management roles</li><li>Strong communicator with proven stakeholder and client engagement skills.</li><li>Strong Talent Acquisition and Talent Development skills</li><li>Ability and keenness to develop 2nd level Leaders.</li></ul><p>Preferred Certifications:</p><ul><li>PMP / PRINCE2 / ITIL / Agile / SAFe</li><li>Cloud (AWS/Azure/GCP Certified)</li><li>Data &amp; Analytics-related certifications (optional but preferred)</li></ul><p><b>Key attributes:</b></p><p>&middot; Proven experience in <b>Client Management, Account Growth, People Management, and Delivery Management</b> connected to software development for international clients (USA and Europe)</p><p>&middot; Good experience in Talent Acquisition: Must passionately drive to get a strong team.</p><p>&middot; Good experience in designing, leading, and validating Learning &amp; Development, skill development mapped to market/client needs</p><p>&middot; Must provide strong <b>Technical Leadership</b> to the team</p><p>&middot; Good leadership, decision-making, and organization skills.</p><p>&middot; Strong attention to detail and multi-tasking skills.</p><p>&middot; Good Communication skills (Oral, written) and client reporting skills.</p><p>&middot; Must be able to manage dispersed teams (India, USA, EU) with onsite and remote execution</p><p>&middot; Strong people development/leadership skills, including mentoring and coaching skills.</p><p><b>Education and Experience:</b></p><p>&middot; A bachelor's degree in Computer Science, Information Technology, or Electronics &amp; Communication or a related field.</p><p>&middot; Experience: 15 to 20 Years</p><p><b>Salary and Benefits:</b></p><p>&middot; As per Industry Standard</p><p>&middot; Employee Stock Appreciation Plan</p><p><b>Other Details:</b></p><p>&middot; Requirement: Immediate (Joining in 2 to 4 weeks)</p><p>&middot; Location: Remote</p><p>&middot; Position: Full-Time</p><p>Job Type: Full-time</p><p>Pay: &#8377;2,088,597.91 - &#8377;4,563,161.58 per year</p><p>Benefits:</p><ul><li>Cell phone reimbursement</li><li>Commuter assistance</li><li>Flexible schedule</li><li>Health insurance</li><li>Internet reimbursement</li><li>Leave encashment</li><li>Life insurance</li><li>Paid sick time</li><li>Paid time off</li><li>Provident Fund</li><li>Work from home</li></ul><p>Application Question(s):</p><ul><li>What is the Total Years of experience </li></ul><p>Experience:</p><ul><li>Application development: 10 years (Required)</li><li>Leadership: 10 years (Required)</li><li>Client Management: 10 years (Required)</li><li>Delivery Management: 10 years (Required)</li><li>USA Clients: 9 years (Required)</li><li>Europe Clients: 10 years (Required)</li></ul>

Director / Sr. Director / Manager– ADMS (+ Data & AI)

Regeneron

<div><p>We are seeking a Senior Manager to join our Clinical Sciences team within Regeneron Genetics Medicine. Qualified scientist with training in the pharmaceutical/biotechnology sector, or academic or clinical setting. You will work closely with supervisor and other members of the cross-functional team, contributes to early development and clinical experimentation for projects for discovery phase through Proof of Concept (POC).<br>
</p><p></p><p>As a Senior Manager, a typical day may include the following:<br>
</p><p><br>
- Supports the cross-functional study team on the following activities, including but not limited to:
</p><p>- Contributes to the writing of sections of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments.
</p><p>- Assists with identifying key internal and external collaborators/advisors, organizes consultations with global subject matter experts
</p><p>- Represents the clinical ECD&amp;ES function on clinical study teams, contributing medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables
</p><p>- Works alongside Clinical Trial Manager to provide day-to-day clinical input to the study team
</p><p>- Drafts portions of the clinical sections in regulatory and clinical documents such as: regulatory agency briefing books, IND/IMPD submissions, investigator&rsquo;s brochure, informed consent forms, IRB/IEC submissions, clinical study reports, abstracts/manuscripts for publication, etc.
</p><p>- Reviews study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc
</p><p>- Trains and support study team and CRO personnel regarding clinical aspects of trial
</p><p>- Assist with medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
</p><p>- Organizes steering committees, advisory boards, and data safety monitoring boards as required
</p><p>- Identifies program, trial or data risks, creates and implements mitigation strategies
</p><p>- Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
</p><p>- Provides background literature searches in support of:
</p><p>- Early clinical strategy in terms of indication selection, study rationale, scientific/clinical endpoints
</p><p>- POC-enabling human studies, First-In-Human (FIH) studies, clinical experimental studies as per clinical strategy<br>
</p><p></p><p>This role may be for you if:<br>
</p><p><br>
- Effective communications (verbal &amp; written) and presentation skills are essential
</p><p>- Must be able to work productively in a fast-paced collaborative environment
</p><p>- Demonstrated/potential for critical thinking skills and sound decision-making<br>
</p><p></p><p>To be considered for this role, you must have a Bachelor&rsquo;s degree. Ph.D., PharmD. or Master&rsquo;s degree in biomedical subject. Additionally, we are seeking 8 years of clinical research/development experience
</p><p></p><div><div><div><div><div><div><div><p>Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries&rsquo; specific benefits, please speak to your recruiter.
<br>
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron&rsquo;s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron&rsquo;s on-site policy and expectations for your role and your location.<br>
<br>
</p><p></p><p>Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
</p><p></p><p>For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
</p><p></p><p>Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
</p><p></p><p><b>Salary Range (annually)
</b></p></div></div></div></div></div></div></div>$150,500.00 - $245,500.00</div>

Senior Manager, Clinical Scientist, Genetics Medicine

Search 10000+ Senior clinical data manager jobs near you this November. New roles added regularly across leading industries. Apply today.