clinical data management manager

TYG Consultant's

<p><b>Clinical Data Manager</b></p><p><b>100 percent onsite-Location: Maple Grove, MN</b></p><p><b>Hours: 8:00am-4:00 PM</b></p><p><b>Duration: This is a 6-month contract with potential to extend highly likely</b></p><p><b>Main purpose of role</b></p><p><b>Summarize the main purpose of the role.</b></p><p>The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans.</p><p>As the customer-face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.</p><p><b>Main responsibilities</b></p><ul><li>Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.</li><li>Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality.</li><li>Facilitate multi-stakeholder discussions to review findings, evaluate impact and develop action plans for correction and continued monitoring.</li><li>Conduct Central Monitoring activities, as described in Central Monitoring Plan.</li><li>Direct all data cleaning activity related to assigned studies.</li></ul><p><b>Qualifications</b></p><ul><li>Bachelors Degree (&plusmn; 16 years) Biology, Health Sciences, Mathematics, Computer Science, or equivalent.</li></ul><p><b>Experience/Background</b></p><ul><li>Minimum 3 years</li></ul><p><b>Experience Details</b></p><ul><li>3 years in clinical operations or healthcare related field.</li><li>Education and work experience in project management, life sciences and/or technical field.</li><li>Knowledge of data collection best practices for clinical trials.</li><li>Knowledge of global clinical operations.</li><li>Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to the desired outcome.</li><li>Proficient at the identification of risks in a process, evaluation of likelihood and impact, and the development of effective mitigation and monitoring strategies that are imperfect yet meet the business need.</li><li>Proficient in the translation of clinical trial requirements to the technical specifications required for effective data collection.</li><li>Skilled at making inferences and connections based on limited information, clearly describing the knowns, unknowns, and alternative explanations.</li><li>Intermediate project management skills; developing a multifaceted plan with complex dependencies and holding peers accountable to adherence to the plan while maintaining positive and collaborative relationships.</li><li>Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.</li></ul><p><b>Licenses and Certifications</b></p><ul><li>None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have.</li></ul><p>Job Type: Contract</p><p>Pay: $42.00 - $44.00 per hour</p><p>Expected hours: 40 per week</p><p>Benefits:</p><ul><li>Health insurance</li></ul><p>Education:</p><ul><li>Bachelor's (Preferred)</li></ul><p>Experience:</p><ul><li>clinical data: 3 years (Preferred)</li><li>EDC (Electronic Data Capture): 3 years (Preferred)</li><li>central monitoring or risk-based monitoring: 3 years (Preferred)</li><li>pharma, medical device, CRO or healthcare industry: 3 years (Preferred)</li><li>overseeing clinical trial data: 3 years (Preferred)</li></ul><p>Ability to Commute:</p><ul><li>Maple Grove, MN 55311 (Preferred)</li></ul><p>Work Location: In person</p>

Clinical Data Manager (EDC/Clinical Operations/Central Monitoring) (Pharma/Healthcare)

Parexel

<div><p><b>Job Summary:</b></p><p>
The Digital Medicine and Translational Imaging Study Manager will play a critical role in ensuring the quality of digital medicine data collected across multiple portfolio studies. This position supports the Digital Medicine and Translational Imaging group's mission to develop and implement novel technologies, with a specific focus on digital health technologies that objectively, remotely, and continuously assess patients over time using novel digital endpoints.</p><p></p><h2 class="jobSectionHeader"><b>
Key Responsibilities:</b></h2><h3 class="jobSectionHeader"><b>
Data Quality Monitoring</b></h3><ul><li>
Review and monitor multiple dashboards to ensure data is being collected as expected</li><li>
Verify participant compliance with device wear periods as specified in protocols</li><li>
Monitor data transmission and device performance (battery/memory capacity)</li><li>
Identify and follow up on necessary actions or issues</li></ul><p></p><h3 class="jobSectionHeader"><b>
Operational Support</b></h3><ul><li>
Review participant and site guides for accuracy and completeness</li><li>
Attend meetings with vendors and study staff to ensure proper site start-up and conduct</li><li>
Address troubleshooting or site-based issues related to digital medicine components</li><li>
Conduct participant follow-ups as needed</li></ul><p></p><h3 class="jobSectionHeader"><b>
Process Improvement</b></h3><ul><li>
Identify opportunities and trends to enhance standardization and efficiency of operational activities</li><li>
Collate lessons learned, frequently asked questions, and study-specific exceptions</li><li>
Contribute to the continuous improvement of digital medicine assessment processes</li></ul><p></p><h2 class="jobSectionHeader"><b>
Qualifications:</b></h2><h3 class="jobSectionHeader"><b>
Knowledge and Experience</b></h3><ul><li>
Experience with trial management of Medical Device and/or Wearable Device studies is required</li><li>
Exceptional knowledge of study management processes and deliverables</li><li>
Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study</li><li>
Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables</li><li>
Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations</li><li>
Experience in clinical research or digital health technology implementation</li><li>
Strong attention to detail and data monitoring skills</li><li>
Excellent communication and stakeholder management abilities</li><li>
Problem-solving mindset with ability to identify trends and improvement opportunities</li></ul><h3 class="jobSectionHeader"><b>
Education</b></h3><ul><li>
Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience required</li><li>
Master's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required</li><li>
A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology</li></ul><p></p><p>
#LI-LG4</p><br>
#LI-REMOTE</div>

Clinical Study Manager, Digital Medicine & Translational Imaging - FSP

Clariwell Global

<ul><li>Assist in entering, updating, and maintaining clinical trial data in databases.</li><li>Ensure accuracy and completeness of data received from clinical sites.</li><li>Review case report forms (CRFs) for discrepancies and inconsistencies.</li><li>Perform data validation checks and raise data queries where required.</li><li>Support in resolving data issues in coordination with site staff and clinical teams.</li><li>Assist in the design, setup, and testing of clinical databases.</li><li>Support in database lock and data transfer activities.</li><li>Maintain accurate documentation and follow standard operating procedures (SOPs).</li><li>Ensure data management processes comply with Good Clinical Practice (GCP) and regulatory guidelines.</li><li>Work closely with data managers, biostatisticians, and clinical research teams.</li><li>Participate in team meetings and ongoing training sessions.</li></ul><p>Job Types: Full-time, Permanent, Fresher</p><p>Pay: &#8377;300,556.97 - &#8377;531,557.30 per year</p><p>Benefits:</p><ul><li>Cell phone reimbursement</li><li>Health insurance</li><li>Paid sick time</li><li>Paid time off</li></ul><p>Work Location: In person</p>

Clinical data management

Central Maine Healthcare

<div>Overview:
<div><b>
Central Maine Healthcare</b> is seeking a <b>Full Time</b>,<b> Clinical Documentation Improvement Manager</b> to join our team!</div><div></div><div><br>
Central Maine Healthcare is an integrated healthcare delivery system serving 400,000 people living in central, western and Midcoast Maine. CMH's hospital facilities include Central Maine Medical Center in Lewiston, Bridgton Hospital and Rumford Hospital. CMH also supports Central Maine Medical Group, a primary and specialty care practice organization. Other system services include the Central Maine Heart and Vascular Institute, a regional trauma program, LifeFlight of Maine's southern Maine base, the Central Maine Comprehensive Cancer Center and other high-quality clinical services.</div><div></div><div><br>
If you are passionate about making a difference and are looking for your next great career opportunity, we look forward to reviewing your application!</div><br>
<div></div>
Responsibilities:
<div>
Manages the CDI program and day to day CDI operations related to the concurrent review of the clinical documentation in the medical record. Collaborates with Senior Director HIM, providers and other healthcare team members to make improvements that result in accurate, comprehensive documentation that reflects completely, the clinical treatment, decisions, and diagnoses for the patient. Utilizes clinical expertise and clinical documentation improvement practices as well as facility specific tools for best practice and compliance with the mission/philosophy, standards, goals and core values of Central Maine Healthcare.</div><div></div><div><br>
Actively participates in planning, administering and evaluating the operations of the Clinical Documentation Improvement Team. Assists in the development of long and short-term goals for the department, promoting quality care and optimal patient outcomes in a fiscally responsible manner. Effectively maintains
<br>
communication with employees, and physicians.</div>
Qualifications:
<ul><li>5+ years acute care hospital clinical RN experience</li><li>
3+ years of experience in Clinical Documentation Improvement</li><li>
Current Licensure from the Maine State Board of Nursing</li><li>
CCDS, CDIP or CCS certification preferred</li><li>
BSN degree or equivalent preferred</li></ul>
Employment Status: Full Time Shift: Days Equal Employment Opportunity:
<div>
CMH actively promotes diversity in its workforce at all levels of the organization. We strive to create and maintain a setting where we celebrate cultural and other differences and consider them strengths of the organization. CMH is an equal opportunity workforce and no one shall discriminate against any individual with regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, genetic information or veteran status with respect to any offer, or term or condition, of employment. We make reasonable accommodations to the known physical and mental limitations of qualified individuals with disabilities.</div></div><div></div>

Clinical Documentation Improvement (CDI) Manager

IQVIA

<div><p>Job Overview
<br>
Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
</p><div>Essential Functions
<br>
<ul><li>Client Management:. serve as primary point of contact for customer on data management deliverables. With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise. With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources. Maintain strong customer relationships. Ensure open communications with customer and IQVIA management to manage and meet contractual obligations. Service Management:. Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables. Establish strong communications with Data Operations team, functional leads, project managers and all other stakeholders. With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects. Serve as the escalation point for unresolved data issues
</li><li>with guidance, work with client data managers, vendors, internal team members for resolution. Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables. With guidance, create and/or review and sign-off on all data management plan (DMP) documents. Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve. With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions. Continuously look for opportunities to improve efficiency of tasks and quality of deliverables. Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution. With guidance, maintain internal tracking databases and systems. Financial Management/Business Development Support:. With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW). Manage SOW/budget. - Review financial reports on a monthly basis and participate in project reviews as requested. - Identify out of scope tasks and track change orders to completion. With guidance, may serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing. With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense). Other:. Provide input on DM process improvements or project solutions to CDM team/CDM department. Provide input on the development and implementation of a new technology or tool. Participate in a focus team or global or local best practice team. Perform other duties as directed by functional manager(s)
</li></ul></div><div>Qualifications
<br>
<ul><li>Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management. Req
</li><li>1-2 years of direct Data Management experience with a minimum of 6 months as a CDM project lead Pref
</li><li>Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and customers. Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and customers.
</li></ul></div><p></p><p>IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com</p></div>

Data Team Lead

INSIGHTEC

<div><p>Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.</p><p></p><p><br>
Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values &ndash; Our Patients, Integrity, Team, Quality and Innovation.</p><p></p><p><br>
Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.</p><p></p><p><br>
Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.</p><p></p><p><br>
Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.</p><p></p><p><br>
The Clinical Project Manager serves as the clinical trial lead and will lead clinical trial initiatives for Insightec. You will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams such as Medical Affairs, R&amp;D, and Quality &amp; Regulatory to advance Insightec&rsquo;s clinical pipeline. The Clinical Project Manager is expected to independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe.</p><p></p><p><b><br>
Key Responsibilities:</b></p><ul><li>
Clinical Trial Management:</li><li>
Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.</li><li>
Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence including implementation of best practices such as quality by design.</li><li>
Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and clinical study reports.</li><li>
Support creation of investigator brochures, clinical evaluation reports, publications and other documentation such as annual reports as applicable.</li><li>
In partnership with R&amp;D Program Management, develop and drive cross functional study timelines related to trial setup and execution</li><li>
Other roles/responsibilities will be defined as needed</li></ul><p>
Team Leadership:</p><ul><li>
Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.</li><li>
Successfully interface with Data Management, Biostatistics and Clinical Monitors to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines</li><li>
Foster a collaborative team environment focused on operational efficiency and continuous improvement.</li><li>
Regulatory and Compliance Oversight:</li><li>
Ensure that clinical trials are conducted in compliance with all applicable regulations and ISO 14155 and ICH-GCP guidelines as applicable.</li><li>
Lead submissions of clinical trial documents to central IRB/IECs as applicable and ensure insurance and recruitment materials are prepared appropriately.</li><li>
Support the preparation and submission of clinical trial applications, including IDEs, PMAs, 501K, INDs, and other regulatory documents with functional leads from regulatory affairs.</li><li>
Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.</li><li>
Budget and Resource Management:</li><li>
Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.</li><li>
Monitor and control trial costs to ensure alignment with project forecasts and company objectives.</li><li>
Negotiate contracts and budgets with clinical vendors and investigators.</li><li>
Vendor and Site Management:</li><li>
Oversee the selection and management of clinical research sites and clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.</li><li>
Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.</li><li>
Perform risk assessment and management, addressing issues proactively to mitigate operational issues.</li></ul><p></p><p><b><br>
Qualifications:</b></p><ul><li>
Bachelor's or Master's degree in life sciences or a related field.</li><li>
7+ Years of experience as a Clinical Project Manager for Class II/III device studies</li><li>
3+ years of regulatory/clinical trial experience in the medical device industry</li><li>
Demonstrates working knowledge of clinical trial design</li><li>
Minimum of three years of experience developing clinical documents including protocols, informed consent, clinical study reports, and investigator brochures among other documents.</li><li>
Knowledge of financial principles in budgeting, budget negotiation, &amp; contracts management.</li><li>
Demonstrates data management skills, tracking study metrics, and adherence to study protocol</li><li>
Fluent in English with oral presentation and training capabilities</li><li>
Able and willing to travel as needed, up to 30%</li><li>
Expertise in GCP and regulatory requirements.</li><li>
Strong leadership and team management skills.</li></ul></div><p></p>

Clinical Project Manager

Gadgeon Medical Systems Pvt Ltd.

<p><b>About Webcardio </b></p><p>Webcardio is a leading provider of innovative cardiac monitoring solutions, offering Doctors and patients real-time, remote cardiac diagnostics through advanced wearable ECG technology. Our mission is to improve cardiac care delivery using AI driven insights and seamless technology.</p><p><b>Role Overview</b></p><p>The Medical Affairs Manager will lead and oversee clinical and medical activities, ensuring high-quality, compliant, and evidence-based clinical research and communication. The role involves managing clinical studies, regulatory compliance, cross-functional collaboration, and scientific communication to support product development, marketing, and sales initiatives.</p><p><b>Key Responsibilities:</b></p><p><b>1. Clinical Study Management</b></p><ul><li>Design, plan, and manage clinical trials, including Real-World Evidence (RWE) studies.</li><li>Ensure adherence to Good Clinical Practices (GCP) and ethical guidelines.</li><li>Collaborate with investigators, Key Opinion Leaders (KOLs), and research sites.</li><li>Collect, analyse, and interpret post-marketing clinical data.</li><li>Conduct retrospective analyses of WebCardio data.</li><li>Lead prospective clinical trials, including protocol design, medical writing, and data analysis to ensure smooth execution.</li></ul><p><b>2. Regulatory &amp; Compliance Oversight</b></p><ul><li>Ensure compliance with regulatory requirements (e.g., CDSCO) and internal standards.</li><li>Prepare clinical documentation for regulatory submissions and approvals.</li><li>Monitor evolving clinical and regulatory standards to ensure ongoing compliance.</li></ul><p><b>3. Cross-Functional Collaboration</b></p><ul><li>Partner with marketing, sales, and other functions to provide clinical insights that enhance strategy and product development.</li><li>Support sales teams in addressing clinical objections with evidence-based information.</li><li>Collaborate with KOLs to gather insights for ongoing and future projects.</li><li>Travel as required to support studies and stakeholder engagement.</li></ul><p><b>4. Scientific &amp; Medical Communication</b></p><ul><li>Prepare clinical study reports, white papers, and publications.</li><li>Present clinical data at conferences, webinars, and to internal and external stakeholders.</li><li>Provide scientific training to KOLs, speakers, and the sales team as required.</li></ul><p><b>Qualifications &amp; Experience:</b></p><ul><li>Degree in Medicine, Pharmacy, or Life Sciences (MBBS,PHD,PharmD, or equivalent).</li><li>Proven experience in clinical study management, medical affairs, or regulatory roles in healthcare/medical device/biotech sectors.</li><li>Strong knowledge of GCP, clinical research methodology, and regulatory requirements.</li><li>Excellent communication, collaboration, and analytical skills.</li><li><b>Place of work- Delhi/NCR (WFH)</b></li><li>Min 3+ Years of experience</li><li>Travel- 25% of time and depends on study requirements.</li></ul><p>Job Types: Full-time, Permanent</p><p>Pay: &#8377;800,000.00 - &#8377;1,200,000.00 per year</p><p>Application Question(s):</p><ul><li>Current CTC</li><li>Expected CTC</li></ul><p>Education:</p><ul><li>Bachelor's (Required)</li></ul><p>Experience:</p><ul><li>clinical study management: 2 years (Required)</li></ul><p>Location:</p><ul><li>Delhi, Delhi (Required)</li></ul><p>Willingness to travel:</p><ul><li>25% (Required)</li></ul><p>Work Location: Remote</p>

Medical Affairs Manager

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