clinical trials manager

Acino

<div>only applicants with requested experience will be consideredArcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide. 
This position, reporting to the Clinical Trial Manager/Clinical Trial Director, will be based in Obour and hired under Legacy Amoun (part of Arcera) employment contract. 
Main duties
<ul>
<li>Serves as a primary operations contact for internal and external study team members on assigned local and global studies/projects</li>
<li>Participation in update of the data base of vendor, including CRO</li>
<li>Responsible for Good Documentation Practice of the study including Sponsor Trial Master File assuring compliance of clinical trials with SOPs and local regulations, ICH, and GCP guidelines.</li>
<li>Assures protocol compliance and training of study personnel, participants and contracted vendors.</li>
<li>Participates in preparation and submission of dossiers for clinical trial applications and clinical documentation in dossiers for new marketing authorizations based on defined regulatory strategy and timelines</li>
<li>Coordinates and support with needed documents when third parties assigned for the submissions to independent ethics committees IECs) and institutional research boards when</li>
<li>Acts as contact person for Clinical activities during Product Development, the Out-licensing Team, Business Development, Global Medical Affairs, PV, and external service providers on all types of new projects clinical trials activities</li>
<li>Participates in due diligence of clinical and related medical documentation</li>
<li>Participates in timely response to requests for supplementary information (deficiency letters) to clinical part from Regulatory Competent Authorities</li>
<li>Assures data administration in internal clinical trials database</li>
<li>Develops and maintains a thorough and up-to-date understanding of the clinical trials regulatory environment, pathways and supporting data requirements</li>
<li>Evaluates and improves regulatory and clinical trials compliance</li>
<li>Develops clinical knowledge and due diligence capabilities within the team</li>
<li>Responsible for achieving assigned KPIs</li>
</ul>
Job Requirements
<ul>
<li>Degree in biomedical sciences (Medicine/Pharmacy/Veterinary/Pharmaceutical Sciences/ Science) or Chemistry. 
</li>
<li>Excellent communication skills, both verbal and written, with a passion for accuracy and attention to detail.</li>
<li>Excellent interpersonal skills &ndash; ability to interact effectively with a diverse group of people from different functions, of different nationalities and at different levels within the company.</li>
<li>Good written and oral knowledge of English.</li>
<li>Skilled at leading non complex projects and clinical trials. 
</li>
<li>Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.</li>
<li>Knowledge of pharmaceutical and clinical trials regulatory processes</li>
<li>In depth knowledge of GCP guidelines, in particular related to the sponsor role of clinical trials.</li>
<li>Understanding of Operational activities in clinical trials.</li>
<li>Leads interactions with third party providers and consultants during all stages of the clinical (and preclinical if needed) clinical trial operational process.</li>
<li>only applicants with requested experience will be considered.</li></ul> 


This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!</div>

Clinical Trial Specialist

<div><h3 class="jobSectionHeader">We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology &ndash; it is all we do &ndash; combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking &ndash; we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.</h3><h4 class="jobSectionHeader">
Position Summary:</h4>
The Clinical Trial Associate coordinates activities on clinical research projects by working with the appropriate clinical teams (e.g. Project Management, Clinical Monitoring, Data Management, Medical Monitoring) on project related activities.<h4 class="jobSectionHeader">
Essential Functions:</h4><ul><li>
Draft project plans and create project documents for review prior to Sponsor review, as assigned.</li><li>
Act as a central contact and provides expert guidance to the clinical team for designated project communications, meeting coordination, meeting minutes, correspondence, and associated documentation.</li><li>
Coordinate activities on clinical trials, including active participation on weekly Sponsor and Investigator calls, maintaining project trackers, and communicating on behalf of the PM to the Sponsor, investigative sites, and vendors as appropriate.</li><li>
Schedule and maintain organization of all clinical project meetings.</li><li>
Accurately update and maintain clinical systems within the appropriate project timeline.</li><li>
Collect and submit documents for assigned Trial Master Files (TMF) per standard guidelines, to ensure continual TMF maintenance in an audit-ready state. Routinely perform TMF document Quality Checks (QCs).</li><li>
Prepare, handle, distribute, file, and archive clinical documentation and reports in a timely manner.</li><li>
Prepare and distribute agendas and minutes from Sponsor and Investigator for team meetings with review from the project management team for accuracy within established deadlines.</li><li>
Maintain accurate team contact lists for every assigned project, proactively gathering information, and updating the contact list. Ensure that the contact list is uploaded to the TMF, as required to meet Standard Operating Procedure timelines.</li><li>
Gather, track, and maintain project and site essential regulatory documents.</li><li>
Provide cross-functional project support to entire Clinical Project team.</li><li>
Prepare and compile trial related materials for investigative sites, including Investigator Site File (ISF) materials, site electronic binders, site instruction manuals, and trial templates, forms, and plans.</li><li>
Acts as Clinical Trial Associate back-up during absences as needed based on individual trial needs.</li><li>
Mentor and assist with training of Clinical Trial Associates.</li><li>
Assist with the development and implementation of clinical policies and procedures.</li><li>
Perform other related duties as assigned.</li></ul><h4 class="jobSectionHeader">
Job Requirements:</h4><ul><li>
Associate degree in a life science or health related field required with Bachelor&rsquo;s degree preferred (experience working in clinical research may be substituted for education at TD2&rsquo;s discretion)</li><li>
Minimum of 4 years of experience in an administrative role.</li><li>
At least 3 years of experience in support of clinical research with preference to oncology research.</li></ul><h4 class="jobSectionHeader">
Required Specialized/Technical Skills:</h4><ul><li>
Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.</li><li>
Advanced written and verbal communication skills</li><li>
Knowledge of GCP, ICH guidelines and clinical trial regulations</li><li>
Ability to work collaboratively in a team environment.</li><li>
Experience managing Trial Master Files and/or Investigative Site Files.</li><li>
Ability to take initiative and work independently with minimal guidance.</li></ul>
Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.
TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran&rsquo;s status, gender, sexual orientation, gender identity, or gender expression.
#LI-Remote
#LI-TD2 
This is a remote position.</div>

Clinical Trial Associate

Gilead Sciences

<div>
 At Gilead, we&rsquo;re creating a healthier world for all people. For more than 35 years, we&rsquo;ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer &ndash; working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world&rsquo;s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 
 
 Every member of Gilead&rsquo;s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we&rsquo;re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 
 
 We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
 
 
 
 Job Description
 
 
 
 Regulatory Affairs Manager Turkiye; is responsible from managing RA submissions &amp; supporting Clinical Trials applications and will serve as a core member of the affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country&rsquo;s applicable legislations.
 
 
 
 Knowledge &amp; Details
 
 
 
 <ul>
 <li>
 Manage regulatory submissions to local HA submissions inc. but not limited to Pre-MAA related activities (GMP &amp; prioritization applications), marketing Authorisation (MA) applications &amp; variations and other MA maintenance applications, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.
 </li>
 <li>
 Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.
 </li>
 <li>
 Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.
 </li>
 <li>
 Manage clinical trial applications, amendments, and notifications. Collaborate with Clinical Operations and the CT Hub to complete CT submissions to MOH timely and interacts with cross-functional teams internally and externally to ensure submission package fulfils the MoH requirements on time.
 </li>
 <li>
 Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.
 </li>
 <li>
 Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.
 </li>
 <li>
 Ensure good and strong relationships with functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with Gilead Sciences Global/Regional RA in order to ensure the success of local and international business results from the regulatory point of view.
 </li>
 <li>
 Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.
 </li>
 <li>
 Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.
 </li>
 <li>
 Actively contribute to local and global initiatives that improve regulatory processes.
 
 
 </li>
 </ul>
 
 Professional Experience / Key Skills
 
 
 
 <ul>
 <li>
 Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.
 </li>
 <li>
 Degree in Pharmaceutical Sciences or equivalent discipline is preferred.
 </li>
 <li>
 Proven ability to prioritize, conduct, and manage time to meet project deadlines.
 </li>
 <li>
 Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.
 </li>
 <li>
 Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.
 </li>
 <li>
 Strong focus on achievement of goals and continuous improvement
 </li>
 <li>
 Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.
 </li>
 <li>
 Having excellence in multiple project management, good communication and interpersonal skills.
 </li>
 <li>
 Be an analytical thinker, problem solver, proactive, initiative taker, creative personality
 </li>
 <li>
 Team player who actively contributes to the team in order to complete tasks, meet goals or manage projects, actively listen others, respect ideas and aim to improve the process.
 </li>
 <li>
 Fluency in spoken and written English.
 </li>
 <li>
 Good decision-making skills are important.
 </li>
 <li>
 Excellent verbal, written, organization skills and interpersonal communication skills required.
 
 
 </li>
 </ul>
 Equal Employment Opportunity (EEO)
 
 
 It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual&rsquo;s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
 
 
 
 For Current Gilead Employees And Contractors
 
 
 
 Please apply via the Internal Career Opportunities portal in Workday.
</div>

Regulatory Affairs Manager

Bristol Myers Squibb

<div>
 
 Working with Us
 
 
 
 Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
 
 
 Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
 
 
 
 Job Title/Role
 
 
 
 Manager, Clinical Trial Risk Analyst
 
 
 
 Department Name/Functional Area
 
 
 
 Trial Delivery Support (TDS)/Trial Risk &amp; Integrity Management (TRIM)
 
 
 
 Position Summary
 
 
 
 The Manager, Clinical Trial Risk Analyst (Mgr CTRA), is a member of the Clinical Trial Risk Management team under Trial Risk &amp; Integrity Management (TRIM).
 
 
 The Clinical Trial Risk Management capability is a critical element of the Risk Based Management (RBM) framework.
 
 
 Each Mgr CTRA will be assigned a certain part of the Bristol-Myers Squibb clinical trial portfolio and will work conjunctly with their peers to ensure consistency across the function in conducting risk oversight to identify potential risks and control strategies. This role is responsible for the remote assessment of risk and data quality analytics that monitor issues and identify emerging risks in study-specific variables (trends / outliers / unusual patterns) through the review of aggregate clinical and operational data leveraging powerful statistical methodologies.
 
 
 The Mgr CTRA will be responsible for study-level risk analysis and reporting and will be key contributor to the clinical study team to support the oversight of the sites/countries/studies for compliance, patient safety, data quality and reliability.
 
 
 The Mgr CTRA role has accountability to evaluate, monitor, escalate and report risks to the Clinical Trial Risk Lead (CTRL) that could potentially have a broad significant and/or systemic impact on quality, compliance, and operational deliverables for discussion with the relevant Governance Committee.
 
 
 The Mgr CTRA forms a key partnership with the CTRL, R&amp;D Quality (Risk Governance and Operations), applicable GDO &amp; TA functions.
 
 
 
 Duties/Responsibilities
 
 
 
 <ul>
 <li>
 Mgr CTRA to contribute to Protocol De-risking process, support identification of critical to success factors, critical to quality factors - including critical data, critical processes
 </li>
 <li>
 Collaborate with the Data Management Lead (DML), Statistician, Global Trial Lead (GTL), Quality Lead, Clinical Trial Physician, Clinical Scientist and other study team members to put together an initial proposal on KRIs (standard and study specific) and Quality Tolerance Limits (QTLs). Proposal to include information on critical data, data source, data flow, data review frequency, external data transfer frequency etc.
 </li>
 <li>
 Responsible to lead and collaborate with the study team in the development of specifications to set up the KRIs, Data Quality Assessments (DQA) and QTLs.
 </li>
 <li>
 Partners with the DML and other data review functions to determine the holistic data review strategy for the study and determines the function-specific review objectives/analytics. Documents the Risk Monitoring data analysis responsibilities in the relevant functional plan.
 </li>
 <li>
 Responsible for regular risk monitoring at study level for and providing a holistic risk report at the agreed frequency. Ensure appropriate escalations of emerging risks (including QTL deviations) to the CTRL to be discussed at relevant governance bodies (e.g. Quality Council/Therapeutic Area leadership) and proactively shares knowledge and insights across the TRIM group.
 </li>
 <li>
 Triages new and previously open signals in preparation for the Risk Review Meetings (RRM) to prioritize the signals for discussion and prepare a list of recommended actions
 </li>
 <li>
 Contribute to the Risk Review discussion to determine if newly opened signals reveal potential risks and require follow-up investigation and if previously opened signals can be closed or need further investigation/monitoring/action. Relates the insights from the CM analysis back to the original risk discussions to share a compelling 'risk story'.
 </li>
 <li>
 Drives or contributes to ongoing risk discussions within the study team throughout the lifecycle of the trial and ensures the risk management plan is updated and remains current
 </li>
 <li>
 Contribute to the development and maintenance of metrics that inform the evaluation of risk monitoring performance and effectiveness.
 </li>
 <li>
 Participation in initiatives / continuous improvement opportunities within the TRIM and broader organizations
 </li>
 <li>
 Supports the strategic direction of Risk Based Management within the business to include leadership of RBM innovation, education and embedding
 </li>
 <li>
 Ensure effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing Risk Management or Risk Monitoring activities on behalf of BMS
 </li>
 <li>
 Takes on additional responsibilities as directed by leadership
 
 
 </li>
 </ul>
 
 Reporting Relationship
 
 
 
 This role will report to a Clinical Trial Risk Analyst Line Manager within the TRIM organization.
 
 
 
 Qualifications
 
 
 
 A minimum of a bachelor's degree in one of the following disciplines or related field: Life Sciences (preferred); Analytics; Data Science; Statistics; Business; is required.
 
 
 At least 3 years in the pharmaceutical industry with sound understanding of drug development and 3 years of experience in clinical trial operations and/or Good Clinical Practice is required.
 
 
 Robust understanding of Risk-Based Monitoring principles (Quality by Design, Risk Assessment &amp; Control) and relevant tools (e.g. RACT, risk analytics platforms, Veeva and other quality systems)
 
 
 Technical expert in data analysis and interpretation using data visualizations to derive meaningful insights; and an ability to effectively tell the story of the data findings
 
 
 Ability to contribute to the development and implementation of data visualizations and analyses to support Risk Management / Risk Monitoring business needs.
 
 
 Robust understanding of GCP, compliance and regulatory expectations. Experience of audits and health authority inspections, root cause analysis and CAPA is desirable.
 
 
 Strong leadership skills with an ability to influence and manage key internal stakeholders
 
 
 Excellent communication, collaboration and teamwork skills with an ability to drive cross-functional stakeholders to consensus.
 
 
 An ability to create a compelling story based on data insights which is meaningful to the target audience.
 
 
 An ability to make the connection between organizational strategy and departmental objectives, and utilize this understanding to drive priorities
 
 
 Open mindset with an ability to be flexible, responsive, and proactive in addressing new challenges, opportunities, and demands.
 
 
 Ability to quickly adapt to changes while maintaining effectiveness and staying aligned with business goals
 
 
 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
 
 
 
 Uniquely Interesting Work, Life-changing Careers
 
 
 
 With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
 
 
 
 On-site Protocol
 
 
 
 
 Responsibilities
 
 
 
 BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
 
 
 Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
 
 
 BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
 
 
 BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
 
 
 BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
 
 
 If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
 
 
 Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
 
 
</div>

Manager, Clinical Trial Risk Analyst

HCA Houston Healthcare

<div>This position is incentive eligible. 
 
 
<h5 class="jobSectionHeader">Introduction</h5>
Last year alone, HCA Healthcare colleagues invested over 156,000 hours impacting our communities. As a Clinical Research Site Manager with HCA Houston Healthcare Medical Center, you can be a manager in an organization that is devoted to giving!<h5 class="jobSectionHeader">
Benefits</h5>
HCA Houston Healthcare Medical Center, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:<ul><li>
Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation.</li><li>
Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more.</li><li>
Free counseling services and resources for emotional, physical and financial wellbeing 
</li><li>
401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service) 
</li><li>
Employee Stock Purchase Plan with 10% off HCA Healthcare stock 
</li><li>
Family support through fertility and family building benefits with Progyny and adoption assistance. 
</li><li>
Referral services for child, elder and pet care, home and auto repair, event planning and more 
</li><li>
Consumer discounts through Abenity and Consumer Discounts 
</li><li>
Retirement readiness, rollover assistance services and preferred banking partnerships 
</li><li>
Education assistance (tuition, student loan, certification support, dependent scholarships) 
</li><li>
Colleague recognition program 
</li><li>
Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence) 
</li><li>
Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.</li></ul>
Learn more about Employee Benefits
Note: Eligibility for benefits may vary by location. 
Come join our team as a Clinical Research Site Manager. We care for our communities and employees! HCA Hope Fund in fourteen years reached a historic milestone: $50 million in help to our colleagues in need. Last year, HCA Healthcare and our colleagues donated $13.8 million dollars to charitable organizations. Apply Today!<h5 class="jobSectionHeader">
Job Summary and Qualifications</h5>
The Site Manager is responsible for the overall clinical operations and management of a specified HCA Research Institute site and its affiliated physician groups. The Site Manager serves as a liaison with local investigators, hospital administration, and local research personnel.
Duties include but are not limited to:
Research Operations Management
<ul><li>Practices and adheres to the &ldquo;Code of Conduct&rdquo; philosophy and &ldquo;Mission and Value Statement&rdquo;
</li><li>Oversee and manage routine operational activities of HRI site research staff
</li><li>Liaise between site research personnel, industry sponsors, and HRI Division Director/leadership
</li><li>Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable
</li><li>Review proposed budgets for adequate coverage and recommends changes to Supervisor
</li><li>Facilitate contracting with hospitals, provider groups, and/or vendors, as needed
</li><li>Engage with revenue integrity to assist with reconciling study payments at the site
</li><li>Actively engage in tracking of studies conducted at the site
</li><li>Oversee study progress at the site from initial submission of feasibility until study closeout
</li><li>Coordinate submission and approval for the Site&rsquo;s Facility Review Committee, if applicable
</li><li>Manage HRI site team responsible for coordinating multiple research studies across several therapeutic areas
</li></ul>Site development:
<ul><li>Work with site personnel, local investigators, and hospital administration to assess site feasibility and resourcing for existing and upcoming research protocols
</li><li>Assist in development and tracking of quarterly site goals
</li><li>Regularly meet with physicians and administrators to assess site performance and investigator satisfaction
</li><li>Provide a research update during Site Administrative meetings (Section meetings, Site Service Line meetings, etc.)
</li></ul>Reporting and Analysis:
<ul><li>Monitor patient enrollment at the site through weekly reports, and reports results to Supervisor
</li><li>Communicate site status and site development through a monthly activity report
</li><li>Facilitate continuing education and training to investigators and site research team members
</li><li>Evaluate operational metrics to continuously improve study quality and/or improve processes
</li><li>Complete performance evaluations for direct reports
</li></ul>Education/Experience:
<ul><li>Bachelor&rsquo;s Degree required; Master&rsquo;s Degree preferred
</li><li>5+ years of experience in healthcare, research, or other science related field
</li><li>Complete performance evaluations for direct reports
</li></ul>Licenses, Certifications, &amp; Training:
<ul><li>Research Certification (ACRP or CCRP) required
</li></ul>&quot;The great hospitals will always put the patient and the patient's family first, and the really great institutions will provide care with warmth, compassion, and dignity for the individual.&quot;- Dr. Thomas Frist, Sr. 
HCA Healthcare Co-Founder
Become a manager with an organization that invests in your career while giving to the community. We are seeking distinguished applicants for our Clinical Research Site Manager opening. Help HCA Healthcare create healthier tomorrows for patients and communities.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.</div>

Clinical Research Site Manager

Ecorgy Solutions Private Limited

Responsibilities:<ul><li>Evaluate clinical procedures and documentation to identify areas for improvement, ensuring adherence to industry standards.</li><li>Conduct compliance audits and assessments to provide continuous improvement feedback and maintain industry compliance.</li><li>Prepare and engage in client audits, including regular mock audits, ensuring preparedness and compliance.</li><li>Stay updated on industry regulations, clinical guidelines, and best practices to ensure compliance and innovation.</li><li>Communicate quality-related issues and recommendations to stakeholders efficiently.</li><li>Engage in quality-focused training and educational programs for continuous professional development.</li></ul>Qualifications:<ul><li>BAMS/ BHMS/ BDS/ Pharm D</li><li>0-5 years of clinical or healthcare setting experience.</li><li>Profound knowledge of medical terminology and clinical processes.</li><li>Good computer skills (Typing speed, MS Excel/Word) - Mandatory.</li><li>Excellent English communication, written and verbal - Mandatory.</li><li>Willing to work in night shifts (10:30PM to 7:30AM) - Mandatory.</li></ul>Job Type: Full-timePay: &#8377;25,000.00 - &#8377;35,000.00 per monthApplication Question(s):<ul><li>How many years of experience do you have?</li><li>Are you okay to work in night shifts (10:30PM to 7:30AM) on regular basis?</li><li>Are you located in Trivandrum or at commutable distance?</li><li>We must fill this vacancy urgently. Are you available immediately for joining?</li></ul>Work Location: In person

Clinical Quality Manager - Doctors (Trivandrum)

Boehringer Ingelheim

<div>We are IMETA
ROPU IMETA is a Regional Operating Unit consisting of 6 mid-sized Operating Units: India, Turkey, Southern Africa (South Africa &amp; Sub Sahara Africa) Northeast &amp; West Africa, Near East &amp; UAE, Saudi Arabia, Gulf &amp; East Africa (SAGEA).
 
IMETA is home to more than 47 nationalities. We are a myriad of color and culture and embracing this diversity is one of our greatest opportunities.
 
We are a powerhouse of talent, and we work together to ensure that we grow, nurture, and retain our talent. Uniting and working together is the key to our success. 
The Opportunity
Are you an experienced professional who wants to be part of a truly innovative and revolutionary team! Join us if you want to make the difference. 
We are hiring a Regional Clinical Trial Assistant (CTA), based at Dubai. The position reports directly to the Head of Clinical Development &amp; Operations IMETA. 
 
The CTA is a member of the regional trial team and is responsible to provide operational expertise and support to the trial team. The CTA is assigned to support the Clinical Trail Manager at Regional trial level, in all administrative tasks during the trial life cycle, including aspects of Trial Master File management and document management and in Clinical Trial Management System updates, among others. 
 
Additionally, CTA closely collaborates with the trial team and ensures that all trial related activities are done on time and according to SOPs, guidelines and internal and external standards.
This is an outsourced role with a third party 
Tasks &amp; Responsibilities:
<ul><li>Leads Trial Document Framework (TMF) &amp; Document management and completion
</li><li>Accountable for vendor related activities, vendor set-up, system access and training, account and report requests
</li><li>Responsible for management of meeting minutes of Trial Level Meetings
</li><li>Accountable for Clinical Trial Management System update and maintenance
</li><li>Support trial team in audits &amp; inspection and CAPA management 
</li></ul>Requirements:
<ul><li>Bachelors in Life Sciences
</li><li>Master&rsquo;s degree will be a plus
</li><li>Minimum 1 year of experience in Clinical Trial administration within pharmaceuticals / CRO
</li></ul><ul><li>Excellent knowledge in VEEVA systems
</li><li>Business fluent in English in its oral and written form
</li><li>Knowledge of additional languages within the region is a plus
</li><li>Should be based in Dubai, with a valid UAE resident visa 
</li></ul> 
What&rsquo;s Next?
We are looking forward to receiving your application! We will then have a look at your profile. If we see a match, we will invite you for a screening interview. 
Screening:
To comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (&ldquo;SPL&rdquo;). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.</div>

Clinical Trial Administrator

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