senior 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

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

Otsuka

<div></div><div><div>Job Summary</div><div>
Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget.</div><div></div><div>
Job Description</div><ul><li>Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs.</li><li>Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents.</li><li>Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites.</li><li>Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs.</li><li>Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments.</li><li>Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.</li><li>Participate in forecasting study expenditures and resourcing needs.</li><li>Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast.</li><li>Provide timely communication of any variances in budget forecast to the Director/Associate Director.</li><li>Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.</li><li>Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned.</li><li>Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency.</li><li>Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF.</li><li>Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned.</li><li>Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities.</li><li>Represent Clinical Management in departmental and cross-functional initiatives, as assigned.</li><li>Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts.</li><li>May have supervisory responsibilities including:</li></ul><div>
o Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.</div><div>
o Assuring compliance with departmental, SOP, compliance, and corporate training</div><div>
o Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.</div><div>
o Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.</div><ul><li>Performs other duties, as assigned.</li></ul><div></div><div>
Qualifications/ Required</div><div>
Knowledge/ Experience and Skills:</div><ul><li>Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations.</li><li>Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW).</li><li>Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management.</li><li>Strong understanding of global regulatory requirements.</li><li>Strong communication, organization, planning, analytical, problem solving, and people management skills.</li><li>Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.)</li><li>Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.).</li><li>Ability to travel up to 25%.</li></ul><div></div><div>
Educational Qualifications</div><div>
Required:</div><ul><li>Bachelor&rsquo;s Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience.</li></ul><div>
Preferred:</div><ul><li>Previous supervisory experience.</li></ul><div>
Competencies<br>
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.<br>
Strategic Thinking &amp; Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.<br>
Patient &amp; Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.<br>
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.<br>
Respectful Collaboration - Seek and value others&rsquo; perspectives and strive for diverse partnerships to enhance work toward common goals.<br>
Empowered Development - Play an active role in professional development as a business imperative.</div><div></div>
Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate&rsquo;s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.<div></div><div><div><div><div><div><div><div><div>
Application Deadline: This will be posted for a minimum of 5 business days.</div></div></div></div></div></div></div></div><div></div><div>
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death &amp; dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.</div><div></div><div>
Come discover more about Otsuka and our benefit offerings; <div>https://www.otsuka-us.com/careers-join-otsuka</div>.</div><div></div><div><div><div><div>
Disclaimer:</div><div></div><div><div><div><br>
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.</div></div><div></div><div><div><br>
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.</div></div><div></div><div><div><br>
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting <div>Accommodation Request</div>.</div></div></div></div></div></div><div></div><div>
Statement Regarding Job Recruiting Fraud Scams</div><div></div><div>
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.</div><div></div><div>
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.</div><div></div><div>
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.</div><div></div><div>
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website <div>https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External</div>.</div><div></div><div>
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka&rsquo;s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: <div>https://www.ic3.gov</div>, or your local authorities.</div><div></div><div>
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development &amp; Commercialization, Inc., and Otsuka Precision Health, Inc. (&ldquo;Otsuka&rdquo;) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka&rsquo;s application portal without a valid written search agreement in place for the position will be considered Otsuka&rsquo;s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.</div></div>

Senior Manager, Clinical Management- Early Phase

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)

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

BioNTech

<div><p>Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany | full time | Job ID: 11063</p><br>
<p></p>
<p><b>
About the Role:</b></p><br>
<p>
</p><p>As a Clinical Data Platform Engineer, you will play a pivotal role in maintaining and enhancing BioNTech&rsquo;s GxP-aligned clinical data platform. Built on Databricks and operating on AWS, this platform is implemented using Terraform-based Infrastructure-as-Code (IaC). Your work will be integral to ensuring the platform's reliability, compliance, scalability, and security while supporting high-quality clinical data workflows. Collaborating closely with multidisciplinary teams, you will contribute to advancing BioNTech&rsquo;s mission of revolutionizing medicine and improving global health.</p><br>
<p></p>
<p><b>
Your Contribution:</b></p><br>
<p></p>
<ul>
<li>Partner with Solutions Architects to design and execute platform integrations and roadmaps</li>
<li>Collaborate with Data Engineers to ensure reliable pipeline operations and scalable platform patterns</li>
<li>Work alongside Clinical Data Managers to enable compliant access and workflow readiness</li>
<li>Engage with Cloud, Security, and QA teams to ensure aligned operations within a validated environment</li>
<li>Manage user provisioning and enforce validated configuration baselines for auditability controls</li>
<li>Operate Databricks workspaces across environments while managing supporting AWS components</li></ul><br>
<p></p>
<p><b>
A Good Match:</b></p><br>
<p></p>
<ul>
<li>Bachelor&rsquo;s degree or equivalent experience in computer science, engineering, or related fields with 5&ndash;8+ years of experience in cloud-based data platforms (AWS), and 2&ndash;4+ years in Databricks administration, workspace configuration, and large‑scale data ecosystems</li>
<li>Experience in GxP/GCP environments, auditability, data integrity requirements, and regulated data systems</li>
<li>Familiarity with clinical data ecosystems (CDR/ODR, CRO data ingestion, study onboarding processes)</li>
<li>Strong understanding of the Product Life Cycle of software products</li>
<li>Expertise in Databricks Delta Sharing, service principal management, and multi-workspace architectures</li>
<li>Advanced troubleshooting skills across Databricks compute/runtime environments, AWS infrastructure components, and Terraform state management</li>
<li>Proficiency in AWS IAM policies, KMS encryption services, Secrets Manager functionality, and S3 cloud storage patterns</li>
<li>Practical experience with IAM configurations, network security protocols, S3 patterns for encryption workflows, and cloud governance frameworks</li>
<li>Applied technical proficiency with IaC tools such as Terraform; GitHub version control; automated CI/CD pipelines</li>
<li>Collaborative mindset with excellent communication skills for multidisciplinary team environments</li></ul><br>
<p></p>
<p>
If the position is filled in the US, the Expected Pay Range is 130,800/year to $209,400/year + benefits, annual bonus &amp; equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Compensation at other locations may vary significantly.</p><br>
<p></p>
<p><b>Your Benefits:</b></p><br>
<p></p>
<p>BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate&rsquo;s qualifications and experience.</p><br>
<p></p>
<p>Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.</p><br>
<p></p>
<p><b>How to apply:</b></p><br>
<p></p><p>Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.</p><br>
<p></p>
<p>Please note:</p>
<p>Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider &lsquo;HireRight&rsquo;. You will be informed accordingly by your BioNTech-Recruiter.</p><br>
<p></p>
<p>We are looking forward receiving your application.</p>
<div><div><p><b>Inspired? Become part of #TeamBioNTech.</b></p>
<p><b>BioNTech, the story</b></p>
<p>At BioNTech, we are more than just a biotechnology company &ndash; we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.
</p><p>Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.
</p><p>Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.</p>
<p>BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!</p>
<p><b>BioNTech - As unique as you</b></p>
<p>www.biontech.com</p></div></div></div><p></p>

(Sr) Manager, Clinical Data Platform Engineer

Xenon7

<div><p><b>About us:</b></p><p>
Where elite tech talent meets world-class opportunities!</p><p>
At Xenon7, we work with leading enterprises and innovative startups on exciting, cutting-</p><p>
edge projects that leverage the latest technologies across various domains of IT including</p><p>
Data, Web, Infrastructure, AI, and many others. Our expertise in IT solutions development</p><p>
and on-demand resources allows us to partner with clients on transformative initiatives,</p><p>
driving innovation and business growth. Whether it's empowering global organizations or</p><p>
collaborating with trailblazing startups, we are committed to delivering advanced,</p><p>
impactful solutions that meet today&rsquo;s most complex challenges.</p><p><b>
About the Client:</b></p><p>
Join one of Egypt&rsquo;s premier financial institutions, renowned for its extensive suite of</p><p>
banking services, including Institutional Banking and Personal Banking.</p><p>
With a global presence through over 50 branches and correspondents, we serve a diverse</p><p>
and dynamic clientele. As we embark on a groundbreaking digital transformation journey,</p><p>
we are committed to leveraging the latest technologies to establish a state-of-the-art data</p><p>
architecture that will redefine our performance and service delivery.</p><h3 class="jobSectionHeader"><b>
Job Summary</b></h3><p>
We are seeking a highly experienced Senior Cloudera Administrator with experience with Cloudera Machine Learning to lead and manage enterprise-scale Hadoop/Cloudera environments. The ideal candidate will have strong hands-on experience with Cloudera platforms, CML, Kubernetes and Openshift and proven leadership managing teams of data engineers, and deep expertise in building and overseeing ETL pipelines. This role requires the ability to design, understand, and communicate complex data architectures and data flows.</p><h3 class="jobSectionHeader"><b>
Key Responsibilities</b></h3><h3 class="jobSectionHeader"><b>
Platform &amp; Cluster Management</b></h3><ul>
<li>Administer, maintain, and optimize Cloudera Hadoop clusters (CDP or legacy Cloudera distributions).</li>
<li>Ensure high availability, performance tuning, capacity planning, and cluster security.</li>
<li>Manage upgrades, patching, monitoring, and troubleshooting of Cloudera services (HDFS, YARN, Hive, HBase, Impala, Spark, Kafka, etc.).</li>
</ul><h3 class="jobSectionHeader"><b>Data Engineering &amp; ETL</b></h3><ul>
<li>Oversee the design, development, and maintenance of ETL/ELT pipelines using tools such as Spark, Hive, Kafka, Airflow, NiFi, or similar.</li>
<li>Review and guide data ingestion, transformation, and storage strategies across batch and streaming workloads.</li>
<li>Ensure data quality, reliability, and scalability of pipelines.</li>
</ul><h3 class="jobSectionHeader"><b>Architecture &amp; Design</b></h3><ul>
<li>Design, understand, and document data storage architectures and data flow diagrams.</li>
<li>Collaborate with stakeholders to define end-to-end data platform architecture.</li>
<li>Translate business requirements into scalable, secure data solutions.</li>
</ul><h3 class="jobSectionHeader"><b>Leadership</b></h3><ul>
<li>Lead and mentor teams of data engineers, providing technical guidance and best practices.</li>
<li>Set standards for development, deployment, monitoring, and documentation.</li>
<li>Work closely with data scientists, analysts, DevOps, and application teams.</li>
</ul><h3 class="jobSectionHeader"><b>Security &amp; Governance</b></h3><ul>
<li>Implement security best practices including Kerberos, Ranger, and data access controls.</li>
<li>Support data governance, lineage, and compliance requirements.</li>
</ul><p><b>
Requirements</b></p><p></p><ul>
<li>
7+ years of experience in data platforms, Hadoop, or big data administration.</li>
<li>Deep experience with CML workspaces, projects, and runtimes.</li>
<li>Strong hands-on experience with Cloudera (CDH/CDP) administration.</li>
<li>Strong experience with containerization (Docker, Kubernetes).</li>
<li>Strong experience with Openshift.</li>
<li>Proven experience managing and mentoring data engineering teams.</li>
<li>Strong background in ETL pipeline design and implementation.</li>
<li>Expertise with Spark, Hive, HDFS, YARN, Kafka, Airflow/NiFi (or similar tools).</li>
<li>Ability to design and draw architecture diagrams for data storage and data flows.</li>
<li>Solid understanding of Linux, networking, and distributed systems.</li>
<li>Experience with cloud platforms (AWS, Azure, or GCP) is a strong plus.</li>
<li>Excellent communication and documentation skills.</li>
</ul><p></p><h3 class="jobSectionHeader"><b>
Nice to Have</b></h3><ul>
<li>Cloudera certification(s).</li>
<li>Exposure to data governance tools and metadata management.</li>
<li>Experience in large-scale enterprise or regulated environments.</li>
</ul><p><b>
Benefits</b></p><ul>
<li><b>
Attractive, market-leading salary package.</b></li>
<li><b>Clear career advancement path with professional development opportunities.</b></li>
<li><b>One-year contract with Xenon7, presenting a significant opportunity for renewal.</b></li></ul></div>

Senior Cloudera Administrator with (CML)

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