clinical project leader

Sanofi

<div>Job title: Clinical Research Director (CRD)
Location: Cambridge, MA / Morristown, NJ 
About the job
Join the engine of Sanofi&rsquo;s mission &mdash; where deep immunoscience meets bold, AI-powered research. In R&amp;D, you&rsquo;ll drive breakthroughs that could turn the impossible into possible for millions.
Our Team:
To support sustainable growth Sanofi Global Development ambition is to be the industry-leading Development organization, using impactful therapeutic innovation that turns hope into reality for people.Therapeutic Areas lead the development of therapies by overseeing the portfolio of development projects and execution of the development programs through the multi-disciplinary Global Project Team (GPT). 
The Clinical Research Director (CRD) is the medical expert in the Development of R&amp;D programs. The role requires a well-organized, strategically and, operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple tasks. 
Our Project:
Lunsekimig is a novel bi-specific nanobody targeting both TSLP and IL-13. Lunsekimig is in development across multiple immunology disease areas. We are seeking a highly motivated clinician-scientist to lead clinical trials in the respiratory space.
About Sanofi
We&rsquo;re an R&amp;D-driven, AI-powered biopharma company committed to improving people&rsquo;s lives and delivering compelling growth. Our deep understanding of the immune system &ndash; and innovative pipeline &ndash; enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people&rsquo;s lives.
Main responsibilities:
The role of the CRD is to:<ul><li>
Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs</li><li>
Collaborate with other medical and clinical scientific experts DMDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction</li><li>
Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc&hellip;)</li><li>
Provide appropriate medical input &amp; support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators</li><li>
Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc&hellip;) and answer to questions from health authorities.</li><li>
Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data</li></ul>
Key responsibilities include:
Leading the clinical development plan strategies<ul><li>
Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)</li><li>
Collaborate with other CRDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams</li><li>
Raise study or project-level issues to the project head and propose related corrective action plans</li><li>
Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects</li><li>
Collaborates with external partners, regulators, scientific experts and internal stakeholders
</li><li>Provide operational expertise to project clinical sub team, as needed</li><li>
Evaluates relevant medical literature and status from competitive products</li></ul>
Lead, Support and oversee the execution of clinical development and studies
<ul><li>Collaborate and communicate appropriately with all function stakeholders (e.g. clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement etc&hellip;), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
</li><li>Develop the abbreviated protocol, the final protocol and protocol amendments
</li><li>Develop/review the Core Study Informed Consent Form (CSICF)</li><li>
Develop/review Study committee Charters</li><li>
Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results
</li><li>Review and provide clinical input across different study documents Vendors RFPs, e-CRF, eCOA etc</li><li>
Provide medical/clinical input to study-related documents such as study plans e.g. Study risk management plan, Monitoring and centralized monitoring plans
</li><li>Participate in the elaboration of training material and presentations at the investigator meetings/local teams trainings</li><li>
Answer to medical questions raised by HA, EC/IRBs, sites</li><li>
Ensure quality of clinical data through continuous data validation, blinded Data review on summary tables or electronic data visualization during clinical trial conduct (AE dedicated review, and Clinical Case review for safety data and statistical surveillance for efficacy data,&hellip;)
</li><li>Ensure trial master file documents readiness and availability, and mandatory trainings linked to the clinical function</li><li>
Lead the study specific committees (IDMC, steering com, adjudication &hellip;) with operational support
</li><li>Co-Develop the SAP in collaboration with biostatistical team</li><li>
Responsible for key results preparation</li><li>
Develop/Review the clinical study report
</li></ul>Responsibilities related to regulatory and safety documents and meetings<ul><li>
Review and/or contribute in the clinical section of the Investigator&rsquo;s brochure, CTA, IND, DSUR, DRMP, RMP</li><li>
Write/review the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP</li><li>
Ensures clinical data meets all necessary regulatory standards</li><li>
Collaborates with the Patient Safety GSO to detect and document any safety signal</li><li>
Participates in Advisory Committee preparation</li></ul>
Scientific Data evaluation and authorship<ul><li>
Participate and author manuscripts and abstracts
</li><li>Establish and maintains appropriate collaborations with knowledge experts or advisory boards</li><li>
Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for the therapeutic area and serves as the clinical advisor to research teams</li></ul> 
About you
Experience:<ul><li>
At least 3 years previous experience in clinical development in pharmaceutical industry or a CRO or medical experience in clinical development in an Healthcare institution. Background in respiratory, allergy, or immunology preferred.</li></ul>
Soft skills:<ul><li>
Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies</li><li>
Excellent problem solving capability</li><li>
Demonstrated capability to challenge decision and status quo with a risk-management approach</li><li>
Ability to negotiate to ensure operational resources are available for continued clinical conduct</li><li>
Very good teaching skills, demonstrated ability to assist and train others</li><li>
Ability to work within a matrix model</li><li>
International/ intercultural working skills</li><li>
Open-minded to apply new digital solutions</li></ul>
Technical skills:<ul><li>
Understanding of pharmaceutical product development and life cycle management</li><li>
Very good Scientific and medical/clinical expertise</li><li>
Very good expertise in clinical development and methodology of clinical studies</li></ul>
Education:<ul><li>
MD (Doctor of Medicine) or equivalent patient care-related medical degree (DO, international equivalents, etc.) required</li></ul>
Languages:<ul><li>
English fluent (spoken and written)</li></ul>
Why Choose Us?<ul><li>
Bring the miracles of science to life alongside a supportive, future-focused team.</li><li>
Discover endless opportunities to grow your talent and drive your career, whether it&rsquo;s through a promotion or lateral move, at home or internationally.</li><li>
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.</li><li>
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks&rsquo; gender-neutral parental leave.</li></ul>
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA
 
#LI-SA
#LI-Onsite
#vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.</div>

Clinical Research Director, I&I

University Of Cincinnati

<div>Current UC employees must apply internally via SuccessFactors<div></div> 
Next Lives at the University of Cincinnati<div> 
Founded in 1819, the University of Cincinnati ranks among the nation&rsquo;s best urban public research universities. Home to more than 53,600 students, 12,000 faculty and staff, and over 360,000 living alumni, UC, a Carnegie 1 institution, combines research prowess with a physical setting The New York Times has called &ldquo;the most ambitious campus design program in the country.&quot; UC's momentum has never been stronger as the anchor of the Cincinnati Innovation District, the oldest cooperative education (co-op) program in the country with students earning $94 million annually through paid experiences, an academic health system, and as a member of the Big 12 Conference. The university contributes $10.6 billion in economic impact to the city and $22.7 billion to the state of Ohio. At UC, next is all of us. Learn more at uc.edu.</div><div></div><div> 
UC is a mission-driven organization where we are committed to student success and positively transforming the community through scholarship and service. We thrive on innovation, making an impact, and fostering an environment where staff and faculty are key contributors to UC&rsquo;s success.</div><div></div><div> 
</div><div><div><div><h2 class="jobSectionHeader">Job Overview</h2></div><div>
As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. In partnership with the UC Health academic healthcare system and Cincinnati Children&rsquo;s Hospital Medical Center, College of Medicine&rsquo;s doctors and faculty are transforming the world of medicine every day. The Department of Neurology &amp; Rehabilitation Medicine is a top-tier department with world-renowned faculty and staff. With world-class research, teaching and medical practice opportunities, why not choose the University of Cincinnati College of Medicine? 
UC is one of the largest employers in the Cincinnati region, employing over 15,000 full-time and part-time faculty, staff and student workers. 
Founded in 1947, the UC Department of Neurology and Rehabilitation Medicine is revolutionizing medicine by connecting discovery and education to world-class care in neurological diseases. Our vision is to be the model organization that integrates neurologic clinical care, research and education. 
The University of Cincinnati, College of Medicine, Department of Neurology and Rehabilitation Medicine is seeking a full-time Clinical Research Project Manager for the NIH-funded StrokeNet Thrombectomy Endovascular Platform (STEP) clinical trial. STEP is a unique, first-of-its-kind platform trial that is looking at various treatments for patients with an Acute Stroke. As the Prime Project Manager of, the candidate will oversee several aspects of national project management for this unique clinical trial. The project manager will work directly with performance sites in the clinical trial. The appropriate candidate should have a clinical background and extensive clinical research experience.</div></div><div><div><h2 class="jobSectionHeader"> 
Essential Functions</h2></div><div><ul><li>
Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines</li><li>
Prepare, oversee, and review documents that are related to the assigned clinical study</li><li>
Arrange or help in organizing clinical study meetings</li><li>
Ensure the availability of necessary resources for the execution of clinical projects</li><li>
Help develop training materials and train clinical staff at sites</li><li>
Communicate with sites regarding key study updates during study webinars and other avenues</li><li>
Lead the clinical project team and various study team meetings</li><li>
Fully involved in resolving issues; take part in procedure improvement initiatives</li><li>
Attain clinical study goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process</li><li>
Work hand-in-hand with the study team to manage documents that are related to the clinical study</li><li>
Responsible for maintaining the protocol versions and manual of procedures for the trial</li><li>
Help prepare safety reports in collaboration with clinical leaders of the project and sites</li><li>
Work collaboratively with team members to ensure regulatory compliance</li><li>
Perform related duties based on departmental need. This job description can be changed at any time</li></ul></div></div><div><div><h2 class="jobSectionHeader"> 
Required Education</h2></div><div><ul><li>
Bachelor&rsquo;s Degree</li><li>
Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.</li></ul></div></div><div><div><h2 class="jobSectionHeader"> 
Required Experience</h2></div><div>
Five (5) years related experience.</div></div><div><div><h2 class="jobSectionHeader"> 
Additional Qualifications Considered</h2></div><div><ul><li>
Possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external people like vendors and external consultants</li><li>
Good problem-solving, organizational, and leadership skills are highly required</li><li>
Ability to work with little or no supervision</li><li>
Ability to pay keen attention to detail at all times</li><li>
Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects</li><li>
Must be able to work as part of a team or in most cases lead a team</li><li>
Must have a &lsquo;one of a kind&rsquo; work ethic, and must exhibit a great level of self-discipline</li><li>
Ability to organize and motivate other members of the study team</li><li>
Proficient user of basic computer applications for the execution of daily project operations</li><li>
Experience in writing clinical study procedures and other clinical documents is a plus</li></ul><ul><li>
Experience in an academic or clinical setting in the area of clinical specialization</li><li>
SoCRA and/or ACRP certification</li></ul></div></div><div><div><h2 class="jobSectionHeader"> 
Physical Requirements/Work Environment</h2></div><ul><li>
Sitting - Continuously</li><li>
Repetitive hand motion (such as typing) - Often</li><li>
Talking - Often</li><li>
Hearing, listening - Often</li></ul></div></div> 
Compensation and Benefits 
UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. (UC Benefits) Eligibility may vary by position and FTE status. Highlights include: 
Salary/Hourly Pay Rate Information: 
Comprehensive Tuition Remission
UC provides tuition remission for you and your eligible dependents, covering tuition costs for nearly all undergraduate and graduate programs offered by the university. 
Robust Retirement Plans
As a UC employee, you won&rsquo;t contribute to Social Security (except Medicare). Instead, you&rsquo;ll choose between state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP), with UC contributing 14&ndash;18% of your salary based on position. 
Real Work-Life Balance
UC prioritizes work-life balance with a generous time-off policy, including:
Vacation and sick time
11 paid holidays and additional end-of-year paid time off (Winter Season Days)
6 weeks of paid parental leave for new parents 
Additional Benefits Include:<ul><li>
Competitive salary based on experience</li><li>
Comprehensive health coverage (medical, dental, vision, prescription)</li><li>
Flexible spending accounts &amp; wellness programs</li><li>
Professional development &amp; mentorship opportunities</li></ul> 
To learn more about why UC is a great place to work, please visit our Careers Page. 
UC is an E-Verify employer. If hired into this position, you will be required to provide satisfactory proof of employment eligibility by providing acceptable, original forms of identification for employment verification via the Federal I-9 employment verification process. Click here for a list of acceptable documents. 
Important: To apply you must create a profile and submit a complete job application through the UC applicant portal. We are unable to consider &ldquo;easy apply&rdquo; applications submitted via other websites. For questions about the UC recruiting process or to request accommodations with the application, please contact UC HR at jobs@uc.edu. 
Equal Opportunity Employer. Building a workplace where all qualified applicants will receive consideration for employment, including Individuals with Disabilities and Protected Veterans. 
REQ: 101946</div>

Clinical Research Project Manager, Department of Neurology & Rehabilitation, STEP

oura

<div><div>Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles.

Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work &mdash; both in and out of the office.</div><div>
As the Clinical Evaluation Lead you will bring your clinical and evaluation expertise into a fast‑moving, technology‑driven environment. While a member of the Clinical Affairs team, you will work day‑to‑day with product, engineering, data science, and AI teams to define, test, and maintain the quality bar for Oura&rsquo;s AI‑powered health experiences. You&rsquo;re the clinician‑scientist who translates our clinical stance and risk thresholds into clear evaluation suites, go/no‑go criteria, and monitoring patterns that keep our guidance safe, trustworthy, and easy to explain.

What you will do:
<ul>
<li>Build trust in Oura&rsquo;s AI‑powered health experiences 
Help define what &ldquo;good enough to ship&rdquo; means for AI behavior across higher‑risk journeys, with a focus on member safety, appropriate use of data, and clear boundaries between wellness and clinical advice.</li>
<li>Design and run clinical evaluation suites 
Translate high‑level evaluation strategy and risk tiers into concrete evaluation plans: scenario libraries, scoring rubrics, and pass/fail criteria that systematically test safety, data use, and communication quality for each release.</li>
<li>Turn evaluation results into clear product decisions 
Summarize evaluation outcomes into concise, decision‑ready views for product managers and clinical leadership &mdash; including go/no‑go recommendations, key risks, and trends over time (for example where quality is improving or regressing).</li>
<li>Make evaluation repeatable and scalable 
Develop templates, checklists, and playbooks so new AI journeys can plug into existing evaluation patterns, rather than starting from scratch. Work with technical partners to connect these suites to internal evaluation tools and release workflows.</li>
<li>Collaborate cross‑functionally on risk and guardrails 
Partner with product, engineering, data science, clinical, regulatory, and outcomes teams to align on evaluation requirements, launch criteria, and monitoring plans. Proactively anticipate risks, communicate clearly about trade‑offs, and maintain a collaborative mindset.</li>
<li>Support clinical governance and external storytelling 
Contribute evaluation inputs to clinical governance forums and help Oura articulate a credible, high‑level narrative on how we evaluate and oversee AI behavior for members, clinicians, and partners.</li>
</ul>
We would love to consider you for this role if you have:
<ul>
<li>Advanced training and experience in a health‑related field, such as:</li>
<ul><li>RN/NP/PA, PharmD, or MD/DO (or equivalent)</li>
<li>MS/MPH in a discipline like epidemiology, health informatics, biostatistics, or related area with demonstrable experience in digital health or clinical product development.</li>
</ul><li>5+ years of experience in healthcare or digital health roles that involved clinical evaluation, quality/safety programs, or algorithm/AI‑enabled products.</li>
<li>Hands-on experience designing or running evaluation or validation workflows for algorithms, AI/ML models, or clinical decision support tools (you have been accountable for safety and correctness, even if you were not the statistician).</li>
<li>Strong clinical literacy and comfort reasoning about symptoms, risk factors, guidelines, and escalation thresholds across common cardiometabolic and general medical scenarios.</li>
<li>Proven ability to work effectively with Product, Engineering, Data Science, and Regulatory/Clinical Affairs, and to influence without direct authority.</li>
<li>Excellent written and verbal communication skills, including the ability to turn complex evaluation concepts into clear frameworks and one‑page summaries for diverse audiences, including leadership.</li>
</ul>
Preferred qualifications:
<ul>
<li>Experience evaluating or building AI‑powered health applications (for example health coaches, symptom tools, or AI‑generated health content) or other high‑risk digital health systems.</li>
<li>Familiarity with evaluation and observability tooling (whether commercial platforms or internal frameworks) for monitoring AI behavior over time.</li>
<li>Background in health systems, digital therapeutics, or regulated health products, especially around evidence generation and safety/quality oversight.</li>
<li>Comfort collaborating on data pipelines and evaluation scripts (for example basic familiarity with SQL/Python or equivalent experience working closely with data and engineering teams).</li>
</ul>
Why you&rsquo;ll love working here:
<ul>
<li>Step in as a direct contributor to Oura&rsquo;s vision, working deeply with cross‑functional colleagues as we expand from wellness into more advanced health and AI‑enabled experiences.</li>
<li>Make a direct impact on millions of members by helping ensure Oura&rsquo;s AI‑powered guidance is safe, clinically grounded, and emotionally intelligent.</li>
<li>Work in a small, high‑impact team setting where your clinical and evaluation expertise directly shapes product direction and infrastructure.</li>
<li>Collaborate across product, engineering, AI/data science, design, regulatory, and clinical operations &mdash; and have your voice heard.</li>
<li>Competitive compensation, benefits, and an opportunity to be part of a company that puts wellness, science, and innovation at the center of what we build.</li>
</ul>
Benefits

At Oura, we care about you and your well‑being. Everyone here has an Oura Ring of their own and we are continually looking for ways to support employee health.

What we offer includes:
<ul>
<li>Competitive salary and equity packages</li>
<li>Health, dental, and vision insurance, plus mental health resources</li>
<li>An Oura Ring of your own, plus employee discounts for friends and family</li>
<li>Generous paid time off, company holidays, and flexible wellness time</li>
<li>Paid sick leave and parental leave</li>
</ul>
Oura takes a market‑based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost‑of‑labor index for that geographic area. While most offers will be closer to the starting range, successful candidates&rsquo; pay will be determined based on job‑related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.
<ul>
<li>Region 1 $198,050 - $233,000</li>
<li>Region 2 $180,200 - $212,000</li>
<li>Region 3 $169,150 - $199,000</li>
</ul>
A recruiter can help you understand how this applies to your location.

We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), Rhode Island (RI), South Dakota (SD), Vermont (VT), West Virginia (WV), and Wisconsin (WI)</div><div><div>

Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics.

We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Disclaimer: Beware of fake job offers! 
We&rsquo;ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note:
<ul>
<li>Our jobs are listed only on the ŌURA Careers page and trusted job boards.</li>
<li>We will never ask for personal information like ID or payment for equipment upfront.</li>
<li>Official offers are sent through Docusign after a verbal offer, not via text or email.</li>
</ul>
Stay cautious and protect your personal details.

To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.</div></div></div>

Clinical Evaluation Lead

Roche

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
 
Die Position
 
The role focuses on the responsibilities to ensure leadership and execution of one or more sponsored interventional trials or managed primary data collection non-interventional studies, the effective and efficient delivery of all operational aspects in accordance with the appropriate quality standards including ICH/GCP and GVPs/GPPs.
 
Your Responsibilities
 
<ul>
<li>Ensures study adherence to appropriate guidelines (ICH GCP/GVP/GPP), relevant regulations and Roche procedural documents. Ensures study inspection readiness at all times. Ensures the completion and finalization of any corrective and preventive action plans resulting from site audits and inspections</li>
<li>Provides operational input and insights into the development of study protocols, Clinical Study Reports, informed consent form and protocol feasibility questionnaires</li>
<li>Promotes operational excellence. Oversees the delivery and maintenance of essential study plans and systems (e.g. site& country selection and monitoring plan; study tracking systems, clinical supply; vendor oversight plan; RBQM or equivalent risk management activities). Ensures accurate tracking and reporting of study metrics</li>
<li>Chairs Study Management Team meetings and organizes the investigator meetings and study kick-off meetings</li>
<li>Establishes and maintains study budgets and approves invoices, identifies and communicates any issues/variances with study budgets and action plans for resolution</li>
<li>Accountable for all vendor related operational study deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Leads vendor selections by reviewing proposals and providing recommendations, reviews and negotiates clinical work orders. Maintains oversight of vendor performance, issues, and their resolution and identifies systematic issues and coordinates any corrective action. Ensures vendors receive appropriate training.</li>
<li>Ensures proper handling of all study close out activities including but not limited to the site close out, final drug accountability, final safety reconciliation and Inspection readiness of Trial Master File documentation.</li>
</ul>
Who you are
 
<ul>
<li>Strong leadership skills developed through leading successful multi-functional matrix study teams through all stages of clinical studies.</li>
<li>Proven strategic capabilities, organizational awareness and proactive planning with embedded contingencies and risk management mindset.</li>
<li>Clear understanding and experience applying ICH/GCP and/or GVP/GPPs and applicable regulations including awareness of quality requirements.</li>
<li>Well-developed written and verbal communication skills demonstrated by an ability to present clear instructions/directions, to motivate your team, negotiate with peers and partners and influence cross functionally.</li>
<li>Excellent problem solving, negotiation and conflict resolution skills</li>
<li>Borderless Collaboration: working closely with other countries/communities/teams, embracing the loop of ‘sharing and learning together’ to co-create Solutions</li>
<li>Budget Management- cost effective management with limited unforeseen cost overruns.</li>
</ul>
Wer wir sind
 
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
 
Gemeinsam können wir eine gesündere Zukunft gestalten.
 
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

Clinical Study Lead

Jackson Health System

<div>Clinical Informatics Specialist, 10 Yr EHR &amp; Info Sys Implement, Full Time, Days
Job Summary 
Clinical Informatics Specialist is responsible for coordination, development, implementation, evaluation, and maintenance of information systems as they relate to the nursing practice, physician's orders, clinical computer communications, and other information technology aspects of patient care. The goal is to integrate the clinical processes, information sciences and information technologies to meet the information needs of the clinical decision makers. 
 
Duties and Responsibilities: 
<ul><li>Assumes Responsibility for the coordination and management of clinical information systems as they relate to nursing practice, patient care, physician order entry, clinical computer communications and nursing informatics.</li><li>
Develops detailed project plans for assigned projects.</li><li>
Prioritizes and coordinates work plans for timely project completion.</li><li>
Monitors outcomes of activities.</li><li>
Produces weekly report of project status and cross-team impacts.</li><li>
Facilitates system design activities to match clinical workflow and process.</li><li>
Applies standards of practice (clinical policies, regulatory requirements, etc.) to system requirements and design.</li><li>
Leads project work groups and meetings.</li><li>
Oversees building and maintenance of various system parameter tables including clinical reference tables, clinical knowledge base, etc.</li><li>
Ensures adequate testing and validation of systems has occurred before any changes are submitted for move into production.</li><li>
Actively participates in training and on-site implementation activities as required to ensure successful start-up.</li><li>
Assists in the development of an operational management plan after initial start-up.</li><li>
Provides on-going recommendations for improvement and system management.</li><li>
Evaluates simple and complex processes to assure technical applications and operational requirements have been met and the resulting implications identified.</li><li>
Acts as a mentor to others.</li><li>
Acts as team leader in the implementation of major systems.</li><li>
Performs other related duties as assigned.</li><li>
Demonstrates behaviors of service excellence and CARE values (Compassion, Accountability, Respect and Expertise).</li></ul>
Experience<ul><li>
Generally requires 5 to 7 years of related experience.</li></ul>
Education<ul><li>
Bachelor's degree and graduate of an approved school of Professional Nursing, Medicine, a Physician Assistant Program or IT or any closely related degree preferred.</li></ul>
Skill 
<ul><li>Ability to analyze, organize and prioritize work accurately while meeting multiple deadlines.</li><li>
Ability to communicate effectively in both oral and written form.</li><li>
Ability to handle difficult and stressful situations with professional composure.</li><li>
Ability to understand and follow instructions.</li><li>
Ability to exercise sound and independent judgment Knowledge and skill in use of job appropriate technology and software applications.</li></ul> 

Credentials<ul><li>
Valid license or certification is required as needed, based on the job or specialty.</li></ul></div>

Clinical Informatics Specialist

CHRISTUS Health

<div>Description 
Summary:
All pharmacists fill orders for drugs, monitor patient drug therapies and provide drug information. Pharmacists provide pharmacy services with compassion, excellence and efficiency. In addition, level II pharmacists participate in management of patient pharmacotherapy and quality medication management within assigned service lines.
Responsibilities: 
<ul><li>Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.</li></ul>
Operational Duties and Responsibilities
<ul><li>Prepares and dispenses drug orders per physician request according to established policies, procedures and protocols.</li><li>
Interprets drug orders (verbal and written) and transcribes/verifies into computerized patient medication record accurately. Maintains, accurate, complete patient drug record.</li><li>
Compounds and dispenses pharmaceuticals including non-sterile and sterile products, chemotherapy and parenteral nutrition products accurately.</li><li>
Issues controlled substances to patient care areas and maintains records as required by law and institutional policies.</li><li>
Provides services efficiently and in a timely fashion.</li><li>
Supervises and directs pharmacy support personnel. Verifies the daily activities of pharmacy technicians</li><li>
Maintains competency required for current job title/position</li><li>
Maintains current pharmacist license. Ensures applicable CE records and licensure are maintained in department files. Attends staff meetings.</li><li>
Completes all competency/skills assessment requirements.</li><li>
Provides analysis of medication use processes and contributes at least one related project per year.</li><li>
Ambulatory care Pharmacist</li><li>
Provides ambulatory pharmaceutical care services utilizing approved protocols and/or collaborative agreement with other providers, including managing patient drug therapy, anticoagulation management, providing patient education, and preparing and/or overseeing the preparation and dispensing of medications. Performs duties in the clinical areas assigned such as but not limited to: anticoagulation clinics, intensive medical home, transition of care, Discharge Medication reconciliation, etc.</li></ul>
Clinical Duties and Responsibilities
<ul><li>Ensures safe, appropriate, cost effective drug therapies for patients according to established policies, procedures, and protocols.</li><li>
Monitors drug therapy regimens for contraindications, drug-drug interactions, drug-food interactions, allergies and appropriateness of drug and dose.</li><li>
Assists with pharmacokinetics consult service and renal drug dosing per hospital protocol.</li><li>
Reads, extracts and interprets information in patient medical records accurately.</li><li>
Detects and reports suspected adverse drug reactions accurately and in a timely manner.</li><li>
Sustains the hospital drug formulary, minimizing non-formulary procurements, utilizing therapeutic substitution protocols and promoting rational drug therapy selection.</li><li>
Provides clinical consultation and clarification to practitioners as appropriate.</li><li>
Provides accurate, adequate and timely drug information to the hospital&rsquo;s professional staff.</li><li>
Provides drug education to patients and their families per institutional protocol.</li><li>
Participates in the quality improvement and medication use review activities of the department. Collects data, conducts monitors and inspections and maintains logs, records and other documentation as assigned.</li><li>
Conducts designated interventions as defined in department Clinical Intervention activities (IV to PO, Renal Dosing, Pharmacokinetic dosing support, Anticoagulation)</li><li>
Baseline departmental standards for reporting interventions for clinical productivity as defined by departmental goals.</li><li>
Participates in antibiotic stewardship, opioid stewardship, and shortage management activities as assigned</li><li>
Attends interdisciplinary rounds when assigned</li><li>
Provides services efficiently and in a timely fashion</li><li>
Contributes to the advancement of the pharmacy department and medication management of the organization through (minimum):</li><li>
Precepting of pharmacy residents and students</li><li>
Assessment of new and ongoing pharmacist competencies</li><li>
In-service of pharmacy and/or nursing staff (1 per year)</li><li>
Participates in departmental or sub-committees as assigned</li><li>
Completes 1 clinical project per year</li></ul>
Occupational Hazards
<ul><li>Potential for exposure to hazardous and toxic substances (including chemotherapeutic, cytotoxic drugs and cleaning solutions), sticks or cuts by needles and other sharp items.</li><li>
Risk 0 exposure category.</li><li>
Potential for musculoskeletal injuries if proper lifting and carrying techniques are not used.</li><li>
Potential exposure to biologic material when participating in direct patient care activities (e.g. patient education, code attendance).</li></ul>
Job Requirements: 
Education/Skills
<ul><li>Doctor of Pharmacy or BS Pharmacy degree required</li><li>
One of the following required: BPS Board Certification, Residency, Fellowship or at least 5 years of hospital experience</li><li>
ASHP Residency Preceptor status required within 180 days of hire (for Ministries with Residency programs)</li></ul>
Experience
<ul><li>PGY-1 and PGY-2 residency completion, Board certification, or 5 years hospital experience required at hire</li></ul>
Licenses, Registrations, or Certifications
<ul><li>Pharmacy state licensure required within 60 days of start date</li><li>
Pharmacist preceptor required within 90 days</li><li>
BLS or ACLS required</li><li>
PALS (for pediatric practice) required</li></ul>
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame. 

Work Schedule: 
5 Days - 8 Hours
Work Type: 
Full Time</div>

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