clinical data manager

Tufts Medical Center

<div><div><div><p><b>Job Profile</b><b> Summary</b></p></div><div><p>
This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. A senior level role that requires advanced knowledge of job area typically obtained through advanced education and work experience. Typically responsible for: managing projects / processes, working independently with limited supervision, coaching and reviewing the work of lower level professionals, resolving difficult and sometimes complex problems.</p></div><p></p><p><b>
Job Overview</b></p></div><div><p><b>
The Center for Clinical Trials at Tufts CTSI and Tufts Medical Center is </b><b>an academic data coordinating center supporting investigator-initiated multisite clinical </b><b>trials. The Clinical Research Data Manager I will be an integral member of the data </b><b>management team, working closely with principal investigators, senior data manager, </b><b>project managers, and biostatisticians to support the operationalization of clinical trial </b><b>protocols into high-quality electronic data systems. </b><b>This role requires hands-on proficiency with REDCap and core clinical trial data </b><b>management workflows. The Data Manager will work within established data </b><b>coordinating center processes to support protocol-driven database design, REDCap </b><b>EDC build and testing (including branching logic, calculated fields, and automated </b><b>notifications), and ongoing data quality control activities. The position emphasizes </b><b>rigorous execution, attention to detail, and accountability for assigned day-to-day data </b><b>management tasks, including supporting query resolution, data cleaning, and assisting </b><b>with the preparation of analysis-ready datasets in compliance with GCP and institutional </b><b>standards.</b></p></div><p></p><div><p><b><br>
Minimum Qualifications</b><b>:</b></p></div><div><p>
1. Bachelor&rsquo;s degree in health science, public health, epidemiology, or another related field including coursework in biostatistics or computerized analytic techniques.</p></div><div><p>
2. Three (3) years of experience as a clinical data manager including developing relational databases for clinical studies using REDCap and/or commercially available EDC systems.</p></div><p></p><div><p><b><br>
Preferred Qualifications</b><b>:</b></p></div><div><p>
1. Experience assisting in the build and management of REDCap databases
</p><p>2. Experience translating protocols into schedules of events, CRFs, and database specifications<br>
3. Experience supporting data quality control, query generation and resolution, and database cleaning and lock, under supervision
</p><p>4. Experience assisting with the preparation of analysis-ready datasets and collaborating closely with biostatisticians</p></div><p></p><div><p><b><br>
Duties and Responsibilities</b><b>:</b> The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.</p></div><p></p><div><p><br>
1. Develops Electronic Case Report Forms, eCRF completion guidelines and edit checks, and trial Data Management Plans.</p></div><div><p>
2. Communicates with trial site staff regarding data submission and the resolution of data queries, and performing descriptive statistical analyses.</p></div><div><p>
3. Leads daily data activities for assigned studies.</p></div><div><p>
4. Designs, develops, tests, validates, and manages Web-based EDC systems to support study outcomes.</p></div><div><p>
5. Writes and implements data management plans, data entry guidelines, and data completion guidelines in compliance with Standard Operating Procedures, Good Clinical Practice (GCP) guidelines, and FDA requirements, if applicable.</p></div><div><p>
6. Supports clinical research reporting for data review, quality-control edit checks, and interim and final analyses.</p></div><div><p>
7. Completes database cleaning and database locks, and assisting research biostatisticians with analysis file creation and statistical analyses.</p></div><div><p>
8. Provides educational support and training to investigators and study site coordinators for the development and implementation of research studies.</p></div><div><p>
9. Mentors data management/entry staff and providing project management support.</p></div><div><p>
10. Serves as credible expert/leader for data management best practices.</p></div><div><p>
11. Establishes priorities and strategies for resource development and core goal setting.</p></div><div><p>
12. Provides positive and effective customer service and contributing to teamwork within and between departments, divisions, programs and other organizations.</p></div><div><p>
13. Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.</p></div><p></p><div><p><b><br>
Physical Requirements</b><b>:</b></p></div><div><p>
1. This is largely a sedentary role, which involves sitting most of the time, but may involve movements such as walking, standing, reaching, ascending/descending stairs, and operating office equipment.</p></div><div><p>
2. Frequently required to speak, hear, communicate, and exchange information.</p></div><div><p>
3. Ability to see and read computer displays, read fine print, and/or normal type size print and distinguish letters, numbers and symbols.</p></div><div><p>
4. Requires manual dexterity using fine hand manipulation to operate computer keyboard.</p></div><p></p><div><p><b><br>
Skills &amp; Abilities:</b></p></div><div><p>
1. Analytical skills.</p></div><div><p>
2. Knowledge of, and high proficiency in, Electronic Data Capture (EDC) and industry data standards (e.g., CDISC).</p></div><div><p>
3. Proven capability of attention to detail and accuracy.</p></div><div><p>
4. Knowledge of GCP guidelines and FDA regulations.</p></div><div><p>
5. Ability to maintain positive and service-oriented culture under stress and deadlines.</p></div><div><p>
6. Flexible and able to adjust to shifting priorities in a fast-paced and dynamic work environment.</p></div><div><p>
7. Superior organizational skills: can prioritize and complete multiple simultaneous efforts with ease.</p></div><div><p>
8. Ability to work independently and as a part of a collaborative team.</p></div><div><p>
9. Knowledge of clinical and translational research.</p></div><div><p>
10. Proficiency in other data management and statistical software (e.g, SAS, SQL, web based EDC) is desirable.</p></div><p></p><p><br>
At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day.</p><p></p><p>
The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals.</p><p></p><p>
Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth&mdash;one of the many ways we invest in you so you can thrive both at work and outside of it.</p><p></p><p><b><br>
Pay Range</b><b>:</b></p><br>
<p></p>
$55,883.46 - $69,859.61</div>

Clinical Research Data Manager I

Kriya Therapeutics

<div><h3 class="jobSectionHeader"><b>Description</b></h3><div><br>
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.<br>
<br>
We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.<br>
<br>
We are proud to have been named <b>Triangle Business Journal&rsquo;s Life Sciences 2024 &ldquo;Best Private Company to Work For,&rdquo;</b> recognized by Forbes as one of <b>&ldquo;America&rsquo;s Best Startup Employers of 2024,&rdquo; and honored as one of BioSpace&rsquo;s &ldquo;2025 Best Places to Work.&rdquo;</b></div><br>
<h3 class="jobSectionHeader"><b>
Role Overview</b></h3><div><br>
The Associate Director, Clinical Data Management Lead will be responsible for the strategic and operational execution of clinical data management activities across Kriya Therapeutics' clinical development programs. This role combines hands-on data management expertise with the orchestration of cross-functional coordination, ensuring data quality, integrity, and regulatory compliance throughout the product development lifecycle. The Associate Director will work closely with CROs, biostatistics, clinical operations, and regulatory teams to deliver high-quality clinical data that supports program advancement and regulatory submissions.<br>
<br>
<b>Key Responsibilities</b>
</div><ul> <li>Lead and execute day-to-day clinical data management activities for assigned clinical studies, including database design, edit check development, data review, and database lock.</li>
<li>Shape and maintain study-specific data management plans, CRF completion guidelines, data validation specifications, and data transfer agreements.</li>
<li>Oversee CRO data management activities, ensuring deliverables meet quality standards, timelines, and contractual obligations.</li>
<li>Serve as the primary data management point of contact for cross-functional study teams, facilitating communication between clinical operations, biostatistics, medical monitoring, and regulatory affairs.</li>
<li>Ensure compliance with FDA, ICH-GCP, and other applicable regulatory requirements across all data management activities.</li>
<li>Develop and approve CRF designs, database structures, edit checks, and coding dictionaries (MedDRA, WHODrug) in collaboration with CRO partners.</li>
<li> Lead data reconciliation activities including SAE reconciliation, central lab data integration, and third-party vendor data transfers.</li>
<li> Support preparation for regulatory submissions by ensuring data packages meet quality standards and timelines, including CDISC (CDASH, SDTM) compliance.</li>
<li>Develop and maintain SOPs, work instructions, and best practices for clinical data management.</li>
<li>Plan audit and inspection readiness activities related to clinical data management, including TMF documentation.</li>
<li> Identify and drive process improvement opportunities and implement solutions to enhance data management efficiency and quality.</li>
<li>Provide data management input into study protocols, statistical analysis plans, and clinical study reports.</li></ul><br>
<h3 class="jobSectionHeader"><b>
Experience &amp; Skills and Work Environment<br>
</b></h3><br>
<div><b>Experience &amp; Skills</b></div><ul>
<li>Bachelor's degree in life sciences, health informatics, computer science, or a related field.</li>
<li>Minimum 12 years of clinical data management experience in pharmaceutical/biotech industry</li>
<li>Advanced degree preferred; or equivalent professional experience</li>
<li>Deep expertise managing data for Phase I-III clinical trials across multiple therapeutic areas Strong knowledge of GCP, 21 CFR Part 11, and global regulatory requirements</li>
<li>Extensive experience in regulatory filings (e.g., IND, CTA, NDA, BLA) and global clinical trials highly desired</li>
<li>Experience in the management/oversight of CROs performing monitoring activities is required</li>
<li>Strong understanding of drug development and program management from pre-IND through regulatory filing</li>
<li>Strong understanding of clinical trial protocols and data flow processes.</li>
<li>Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.</li>
<li>Excellent written and verbal communication skills are required.</li>
</ul><div><b>Work Environment</b></div><ul>
<li>Primarily desk-based, generally in an office or home office setting.</li>
<li>May involve extended periods of sitting and computer use.</li>
<li>Ability to stand for extended hours.</li>
<li>Ability to climb ladders/steps.</li></ul><br>
<h3 class="jobSectionHeader"><b>
Life at Kriya</b></h3><div><br>
<b>
Discover True Collaborative Teamwork</b><br>
We have an ambitious set of goals, but our confidence &ndash; and our inspiration &ndash; stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.<br>
<br>
We&rsquo;re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.<br>
<br>
<b>Rewards &amp; Benefits</b>
</div>Time Off &amp; Work-Life Balance: Flexible Time Off Paid Parental &amp; Medical Leave<ul><li> Paid Company Holidays</li>
<li>Health &amp; Wellness:<b> </b>Fertility &amp; Family Building Benefits Medical, Dental, and Vision Insurance Employee Assistance Program (EAP) Life Insurance Short- and Long-Term Disability Coverage</li>
<li>Financial Security:<b> </b>Equity 401(k) with Company Match Identity Theft Protection</li>
<li>And More!</li></ul><br>
<h3 class="jobSectionHeader"><b>
About Kriya Therapeutics</b></h3><div>
won't let me leave this section blank</div><div><i><br>
Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.</i></div><div><i>
</i></div><div><i>
All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.</i></div></div>

Associate Director, Clinical Data Management Lead

Norton Healthcare

<div>Responsibilities:
<div>
Clinical Research Assistant (CRA) provides support to the research team by collecting, entering, abstracting, and managing the study data for sponsor data systems, publication, or other reporting. The CRA may also assist the Clinical Research Nurse (CRN) and/or Clinical Research Coordinator (CRC) in the set-up and execution of clinical research protocol procedures and associated administrative responsibilities. In some cases, the CRA may coordinate retrospective, quality, and other non-therapeutic research trials under Principal Investigator direction. Additionally, the CRA is responsible to maintain research medical equipment; accurately maintain logs; perform protocol-related tasks as assigned (within scope of practice); inventory, store, order and maintain study-related equipment/ supplies.</div>
Qualifications:
<div><b>
Required:</b></div><ul><li>
One year in a research or healthcare setting</li></ul><div><b>
Desired:</b></div><ul><li>
One year in data entry or abstraction</li><li>
Associate Degree</li><li>
Certified Clinical Data Manager OR Certified Clinical Research Associate OR Certified Clinical Research Coordinator OR Certified Clinical Research Professional OR Certified Medical Assistant OR Certified Tumor Registrar</li></ul></div>

Clinical Research Assistant, NCIRP Research Operations, Days

Core Clinical Servuces

<p><b>Job Title:</b> Healthcare Data Management Executive. (BAMS/BHMS/BEMS/BSMS Graduate)<br/>Pune based candidates only<br/>Work from office only.</p><p><b>Company:</b> Core Clinical Services</p><p><b>Location:</b> 1st Floor, Tilak Bhavan, Lal Bahadur Shastri Road, Near Alka Talkies, Pune - 411030</p><p><b>About the Company:</b></p><p>Core Clinical Services is a Pune-based Healthcare IT company offering excellent career opportunities in Clinical Data Management and Analysis. We are looking for enthusiastic and skilled professionals with a background in BAMS, BHMS, BEMS &amp; BSMS to join our dynamic team.</p><p><b>Job Description:</b></p><p>We are seeking dedicated BAMS, BHMS, BEMS &amp; BSMS graduates for the role of Healthcare Data Management Executive. The ideal candidate should have a strong foundation in clinical and medical knowledge, along with proficiency in MS Office (Word &amp; Excel).</p><p><b>Key Responsibilities:</b></p><p>&middot; Utilizing medical and clinical expertise to ensure data accuracy.</p><p>&middot; Working with MS Office tools, primarily Word and Excel, for data entry, analysis, and reporting.</p><p>&middot; Maintaining high-quality standards in documentation and analysis.</p><p>&middot; Ensuring timely completion of allocated tasks while adhering to quality standards.</p><p>&middot; Job involves Clinical and Medical Data Analysis, Clinical Data Management and Preparing Summaries.</p><p>&middot; Should be able to understand and grasp the key concepts of the job.</p><p><b>Required Skills and Qualifications:</b></p><p>&middot; Must hold a BAMS, BHMS, BEMS &amp; BSMS degree (completed after 2023).</p><p>&middot; Experience: Freshers to 1 year.</p><p>&middot; Strong knowledge of clinical and medical concepts.</p><p>&middot; Proficiency in MS Office (Excel &amp; Word).</p><p>&middot; Good analytical and problem-solving skills.</p><p>&middot; Strong attention to detail and accuracy in work.</p><p>&middot; Ability to work in a structured and deadline-driven environment.</p><p><b>Should understand and write English without grammatical errors.</b></p><p><b>Work Schedule:</b></p><p>&middot; Monday to Saturday</p><p><b>Benefits:</b></p><p>&middot; Incentives and bonuses for completion of allocated target work without quality issues.</p><p>&middot; Good growth prospects in Clinical Data Management and Analysis.</p><p>&middot; Permanent/Full-time job/ fixed shift opportunity</p><p>&middot; Training will be provided for the same.</p><p><b>How to Apply:</b></p><p>Interested candidates can contact us at: <b>+91 9881122488</b>/ hr@coreclinicals.com</p><p>Job Types: Full-time, Permanent, Fresher</p><p>Pay: ₹18,000.00 - ₹22,000.00 per month</p><p>Application Question(s):</p><ul><li>Which degree you have BAMS/BHMS/BEMS/BSMS?</li></ul><p>Work Location: In person</p>

Healthcare Data Management Executive (Doctor)

ICON plc

<div>Senior Clinical Data Science Lead - Bangalore, 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 Senior Clinical Data Science Lead to join our diverse and dynamic team. As a Senior Clinical Data Science Lead at ICON, you will play a pivotal role in leading the analysis, interpretation, and management of clinical data to drive the success of our clinical trials. You will contribute to the advancement of innovative treatments and therapies by overseeing data science initiatives and ensuring data quality and integrity across studies.</div><div></div><div>
What You Will Be Doing:</div><ul><li>
Leading the development and implementation of clinical data management strategies to optimize data collection, analysis, and reporting.</li><li>
Collaborating with cross-functional teams to ensure the accurate integration of data science techniques into clinical trial designs.</li><li>
Overseeing the analysis of clinical data to provide actionable insights that inform study decisions and outcomes.</li><li>
Providing strategic guidance on data governance, quality control, and compliance with regulatory requirements.</li><li>
Establishing partnerships with key stakeholders to leverage the latest advancements in data science and technology in clinical research.</li></ul><div>
Your Profile:</div><ul><li>
Advanced degree in a relevant field such as data science, biostatistics, or life sciences.</li><li>
Extensive experience in clinical data science, with a strong focus on data management and analysis in clinical trials.</li><li>
Strong leadership skills and a proven ability to manage cross-functional teams in a fast-paced, matrix environment.</li><li>
Expertise in data analysis tools, statistical software, and data visualization techniques.</li><li>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive change in a complex organization.</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>

Senior Clinical Data Science Lead

<div>RBQM Operations Manager<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 Clinical Data Risk Manager to join our diverse and dynamic team. As a Clinical Data Risk Manager at ICON, you will play a vital role in leading risk management strategies for clinical trials, ensuring the integrity and quality of data throughout the research process. You will contribute to the success of our clinical programs by identifying potential risks, developing mitigation plans, and collaborating with cross-functional teams to enhance data management practices.</div><div>
What You Will Be Doing:</div><div></div><ul><li>
Leading risk assessments on clinical trial data to identify, evaluate, and mitigate potential risks.</li><li>
Developing and implementing risk management frameworks and protocols in alignment with regulatory standards.</li><li>
Collaborating with stakeholders to ensure effective communication of risk findings and recommendations.</li><li>
Monitoring data quality and compliance throughout the trial lifecycle, reporting on risk status and action plans.</li><li>
Providing training and guidance to teams on best practices for data risk management.</li></ul><div>
Your Profile:</div><div></div><ul><li>
Advanced degree in life sciences, statistics, or a related field.</li><li>
Significant experience in clinical data analysis and risk management within a clinical research setting.</li><li>
Strong analytical and problem-solving skills, with a proven ability to develop risk mitigation strategies.</li><li>
Excellent communication and leadership skills, capable of influencing and driving change across teams.</li><li>
Familiarity with regulatory requirements and industry standards related to clinical data management and risk assessment.</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>

RBQM Operations Manager

Regeneron

<div><p>The Manager, Clinical Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management results that meet Regeneron standards and within timelines.
</p><p></p><h2 class="jobSectionHeader"><b>A typical day might include the following:
</b></h2><ul><li>Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects.
</li><li>Supervises direct DM reports for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality results and within the budget. Mentor junior data managers for skills advancement. If required, leads and performs clinical data management tasks for studies.
</li><li>Supervises and ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOP&rsquo;s and work instructions in compliance with applicable regulations.
</li><li>Reviews and approves for final archival of project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF.
</li></ul><p></p><h2 class="jobSectionHeader"><b>This role might be for you if:
</b></h2><ul><li>Supervises DM direct reports for the initiation and approval of the building, and validation of clinical databases, subsequent changes in clinical databases and data validation activities. Coordinates with clinical project team for issue resolution.
</li><li>Contributes to development of Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
</li><li>Ensures adequate management of CROs and vendors in the therapeutic projects and coordinates all data management functions.
</li><li>Establishes goals, expectations and accountabilities for direct reports. Regularly reviews DM performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures. Responsible for coaching, handling training and leading the direct reports.
</li></ul><p></p><h2 class="jobSectionHeader"><b>To be considered
</b></h2><ul><li>Bachelor&rsquo;s degree in mathematics, Science or a related field, along with at least 8 or more years of clinical data management experience in biotech, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus. Previous managerial experience is preferred
</li><li>Directed and comfortable working in teams with the ability to work and operate independently within a tight time line environment. High degree of creativity, latitude and attention to detail required.
</li><li>Knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong communication, leadership and business development skills required.
</li><li>Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with JMP and SAS a plus.
</li></ul><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>$114,800.00 - $187,400.00</div>

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