study manager

Wood

<div>
 
 Job Description
 
 
 
 Are you ready to guide clients through the evolving energy markets &ndash; balancing profitability with sustainability and ESG commitments?
 
 
 Can you lead the way in solving complex technical challenges and unlocking innovative solutions for our clients?
 
 
 Through this highly rewarding role you will be shaping the world and creating a bright future for yourself.
 
 
 Wood is currently recruiting for Study Managers to join our Process &amp; Chemicals Consulting Team based in Muscat, Oman.
 
 
 
 Responsibilities
 
 
 
 As an experienced engineer, with a strong appreciation of process design and an interest in the holistic aspects of Greenfield and Brownfield projects, you will grow your career through taking Commercial and Client Stakeholder management responsibility for delivering across the pre-FEED phases of project implementation (pre-feasibility, concept, feasibility, pre-FEED etc).
 
 
 Focusing on predictable project delivery against key internal and external metrics of cost, schedule and quality you will steer your project team to develop the technoeconomic solution that guides your client to successfully achieve the next stage in their decision gate process.
 
 
 You will interface with a multi-disciplinary team of highly capable Subject Matter Experts and Consultants to deliver best in class solutions that will ensure high customer satisfaction. This will lead to opportunities for further advancement of your career in multiple directions.
 
 
 This is a fantastic role for a leadership focused process engineer with a real passion for developing their own leadership style and project management capabilities while making a difference in both Energy Security and Energy Transition.
 
 
 
 The Key Objectives For This Role Are
 
 
 
 <ul>
 <li>
 Develop and manage strong customer relationships that ensure Wood is the Client&rsquo;s contractor of choice for early phase studies
 </li>
 <li>
 Oversee all aspects of project management and delivery of pre-FEED scopes of work in accordance with the contract whilst managing project risk profile and change
 </li>
 <li>
 Manage and lead the project team to achieve the health, safety, environmental, schedule, cost and quality requirements of the study. Ensure that Wood&rsquo;s and Client&rsquo;s Health and Safety, Environmental and Quality Management Procedures are followed
 </li>
 <li>
 Grow in leadership qualities and capability providing optimised solutions to Client&rsquo;s complex multi-faceted problems; articulating these in a way that allows Clients to readily present to their own internal and external stakeholders
 </li>
 <li>
 Develop compelling and competitive proposals that readily demonstrate to Clients the best way to deliver their project
 </li>
 <li>
 Challenge the status quo, support and be part of an award-winning group that seeks to grow and develop to be the best it can be
 </li>
 <li>
 Be a role model for Wood&rsquo;s behaviours; encouraging a collaborative, inclusive and supportive team that can have fun and enjoy the work we deliver
 
 
 </li>
 </ul>
 
 Our Clients and Projects
 
 
 
 
 It&rsquo;s a future for all of us.
 
 We aspire to shape a better tomorrow by unlocking solutions that address the biggest challenges facing our clients and our society.
 
 
 Across our Consulting business, we service a varied client base worldwide including; National, International and Private Energy Companies, World Class private developers (major and independent), investment banks, utilities &amp; power generation companies and Technology Providers. We provide value added services bespoke to the clients' requirements across; advisory services, technical specialists, project management, owners engineering through all pre-FEED project phases as well as supporting Wood Project and Operations Business Units through FEED and EPC phases of the project lifecycle.
 
 
 Our specialisms are across Upstream developments, New Green and Blue Energies, Hydrogen and Hydrogen vectors (e.g. Methanol and Ammonia), Carbon Capture Utilization and Storage (CCUS), Fuels &amp; Chemicals.
 
 
 
 Qualifications
 
 
 
 
 What we can offer
 
 
 
 <ul>
 <li>
 A caring team culture; we support each other professionally and personally, encouraging knowledge sharing across all areas of the business
 </li>
 <li>
 Meaningful and interesting projects delivered to leaders of industry across the energy transition, emerging and conventional energy sectors
 </li>
 <li>
 Flexible working arrangements that balance client, team and individual needs offering hybrid and remote working where relevant
 </li>
 <li>
 Commitment to Diversity and Inclusion; we are an organisation actively committed to diversity and inclusion across our business
 </li>
 <li>
 Competitive renumeration package with regular reviews to ensure we are rewarding at the right level in line with the market
 </li>
 <li>
 Commitment to continued professional development; development plans that are tailored to your individual needs and interests
 </li>
 <li>
 Global connections; join experts around the world who are at the leading edge of our industry, shaping the standards of our profession
 
 
 </li>
 </ul>
 
 If all of this sounds good to you, review the requirements of the position below, then follow the link to apply and start your journey with Wood.
 
 
 
 
 Skills And Qualifications
 
 
 
 You may read these details and consider not applying because your knowledge, experience and skills base doesn&rsquo;t fully cover every item listed, and that&rsquo;s understandable. However, we&rsquo;d still like to hear from you. At Wood, we understand and acknowledge that everyone is different, we are committed to equal opportunities and want to access all the talent that is out there. We are committed to attracting a broad range of skills, knowledge and experiences and embrace differences. So even if you feel you don&rsquo;t have everything listed, but think you have some of the experience, knowledge or skills to help us unlock solutions to the world&rsquo;s most critical challenges and grow your potential&hellip;.do apply.
 
 
 
 Expected
 
 
 
 <ul>
 <li>
 Degree qualified in a relevant Engineering or Science Discipline
 </li>
 <li>
 Commercial awareness of project delivery
 </li>
 <li>
 Understands the levels of detail required to support the early phase decision making process for pre-FEED phases (pre-feasibility, concept, feasibility, pre-FEED etc)
 </li>
 <li>
 Ability to engage early with clients, understand their drivers and pain points to jointly develop value-add studies
 </li>
 <li>
 Experienced in chairing meetings and facilitating workshops
 </li>
 <li>
 Capable of motivating and leading multi-disciplined and multi-cultural teams, encouraging a collaborative and inclusive culture
 </li>
 <li>
 Ability to develop compelling proposals to solve client problems, including manhour, execution strategy and schedule development.
 </li>
 <li>
 Communicates effectively to build collaboration and influence stakeholders
 </li>
 <li>
 Thinks strategically, takes decisions and delivers results
 </li>
 <li>
 Experienced in the downstream sector &ndash; refining, fuels and chemicals
 
 
 </li>
 </ul>
 
 Desirable
 
 
 
 <ul>
 <li>
 Chartered Engineer or Scientist
 </li>
 <li>
 Member of an appropriate professional institution
 </li>
 <li>
 Some level of qualification from Association of Project Management or similar
 </li>
 <li>
 Commercial exposure through responsible positions in Proposals, Legal or Commercial
 </li>
 <li>
 Experience in FEED, EPC, Commissioning and / or Operations such that Clients recognise the experience from later phases being considered in their early project phase
 </li>
 <li>
 Experience in New Energies (Hydrogen, CCUS, Low Carbon Fuels etc)
 </li>
 <li>
 Proficient in the use of project scheduling, estimating and cost accounting tools and methods
 
 
 </li>
 </ul>
 
 About Us
 
 
 
 Wood is a global leader in consulting and engineering, helping to unlock solutions to critical challenges in energy and materials markets. We provide consulting, projects and operations solutions in 45 countries, employing around 25,000 people. www.woodplc.com
 
 
 
 Diversity Statement
 
 
 
 We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.
</div>

Study Manager

Retinal Consultants

**Overview:** We are seeking a dedicated Study Manager to join our team. The ideal candidate will have experience in clinical trials management and possess strong knowledge of clinical development processes. **Responsibilities:** - Manage and oversee clinical trials from initiation to completion - Ensure compliance with HIPAA regulations and other relevant standards - Review and maintain accurate documentation throughout the study - Conduct vital signs assessments and phlebotomize when necessary - Collaborate with clinical laboratory staff to ensure accurate results - Implement compliance management strategies to uphold study integrity **Experience:** - Proven experience in clinical trials management - Familiarity with HIPAA regulations and compliance standards - Ability to review and interpret clinical trial documentation - Knowledge of phlebotomy techniques - Strong understanding of clinical development processes This position offers the opportunity to work in a dynamic environment where you can contribute to cutting-edge research initiatives. If you are passionate about clinical trials and ensuring high-quality study outcomes, we encourage you to apply.Job Type: Part-timePay: $20.00 - $25.00 per hourBenefits:<ul><li>Paid time off</li></ul>Work Location: In person

Ophthalmology Clinical Trial Coordinator

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

KPS Life

<div><div>Opportunity Details
</div><div><div><div><div>On Assignment</div>
Clinical Oversight Manager (COM) - USA West Coast
 </div><div></div><div>Remote NE USA</div><div> 
</div></div></div><div>The primary responsibility of the (Clinical) Oversight Manager (C)OM) is to ensure adequate Sponsor oversight of 
the conduct, monitoring and management of one or more clinical studies and assigned monitors at clinical study 
sites, within the assigned country or region. 
The (C)OM):<ul><li>
contributes to development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan.</li><li>
contributes to the definition of appropriate standards and quality indicators for site management and monitoring.</li><li>
ensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards.
</li><li>addresses issues identified with study conduct, monitoring and site management with Sponsor&rsquo;s management, are appropriately communicated/escalated and follows up through resolution.</li><li>
May conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed.</li><li>
reviews the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region.</li><li>
may assist with translations or verification of translations.</li><li>
implements approved communication plans with external strategic partners or CROs.</li><li>
supports the collection of key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality.</li><li>
reviews monitoring visit reports for finalization/consistency/issues according to study monitoring plan.</li><li>
utilizes available tools/systems to assess vendor and site performance.</li><li>
ensures inspection readiness at the study sites and follow up corrective/preventive actions.</li><li>
maintains good communication and working relationships with investigators, internal stake-holders and external services providers (CROs).</li><li>
provide input into study feasibility for assigned sites/countries/region and supports the on-time delivery of a clinical study data, globally (if applicable</li></ul> 
The (C)OM) will have:<ul><li>
computer literacy in appropriate software(s).</li><li>
the ability to work well within a matrix environment with excellent interpersonal (written and verbal) and decision-making skills.</li><li>
demonstrated innovation skills, drive, energy and enthusiasm to deliver the study program objectives.</li><li>
demonstrated management of all clinical study aspects (developing a protocol to clinical study report).</li><li>
the ability to identify, solve and escalate issues that arise at study sites and within site management</li><li>
comprehensive/extensive knowledge of ICH guidelines/GCP and remains current on medical/scientific aspects.</li><li>
demonstrated project management skills i.e. (simultaneous management of multiple vendors, sites and studies. Possesses excellent planning, time management and coordination skills.</li><li>
demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.</li></ul>
The (C)OM) will have:<ul><li>
a degree (BSc/MSc or equivalent preferred) in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area.<ul><li>
other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).<ul><li>
a minimum of 8+ years&rsquo; relevant clinical research (or related) experience.</li><li>
6+ years&rsquo; experience in monitoring and site management of industry sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent).</li><li>
a thorough understanding of the drug development and clinical trial process.</li><li>
the ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary.</li><li>
the ability to participate in preparation, conduct and follow up of audits and site inspections.</li><li>
active management experience of countries and sites in a region.</li><li>
thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.</li></ul></li></ul></li></ul></div></div>

Clinical Oversight Manager (COM)

Milestone One

<div>
 
 Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.
 
 
 
 
 
 
 Job Description
 
 
 
 
 The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager.
 
 
 
 
 
 
 In this job you will:
 
 
 
 
 
 <ul>
 <li>
 Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution.
 </li>
 <li>
 Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time.
 </li>
 <li>
 Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria.
 </li>
 <li>
 Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff.
 </li>
 <li>
 Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed.
 </li>
 <li>
 Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment.
 </li>
 <li>
 Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual.
 </li>
 <li>
 Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution.
 </li>
 <li>
 Track patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments.
 
 </li>
 </ul>
 <ul>
 <li>
 Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions.
 </li>
 <li>
 Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding.
 </li>
 <li>
 Assist site staff with maintaining appropriate temperature monitoring for study products and supplies.
 </li>
 <li>
 Support the contract and budget negotiations and oversees Investigator/Site Payments.
 </li>
 <li>
 Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the protocol before site implementation.
 </li>
 <li>
 Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc.
 </li>
 <li>
 Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections.
 </li>
 <li>
 Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs).
 </li>
 <li>
 May be involved in the on-site training of additional staff as part of the SEO or other education programs.
 </li>
 <li>
 Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements.
 </li>
 <li>
 Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II.
 </li>
 <li>
 SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope.
 
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 
 
 Education
 
 
 
 
 
 
 Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects.
 
 
 
 
 Nephrology experience preferred.
 
 
 
 
 
 
 Certifications
 
 
 
 
 
 <ul>
 <li>
 Current Good Clinical Practice (GCP)
 </li>
 <li>
 International Air Transport Association (IATA)
 </li>
 <li>
 Current Basic Cardiopulmonary Resuscitation (CPR)
 </li>
 <li>
 Phlebotomy certification unless part of active professional licensure (RN or LPN)
 </li>
 <li>
 Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified.
 
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 
 
 Located in South Cook/ Will County, Chicago (On-site position).
 
 
 
 
 
 If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!
 
 
 
</div>

Clinical Study Coordinator

Zymeworks Inc

<div>Company Description 
Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company&rsquo;s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera&reg; (zanidatamab-hrii) and other licensed products and product candidates such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the early-stage development of innovative medicines. We are a global company headquartered in Vancouver BC, with operations in Bellevue WA, Dublin IRE, and Singapore. 
Why Work With Us
Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance. 
This role will be located in either Vancouver, BC or Bellevue, WA or New York, or Singapore and is hybrid with a minimum of 3 days per week onsite. 
What You'll Do<ul><li>
With appropriate supervision, manages the design and implementation of study protocols for a clinical development program, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, and emerging issues. Oversees project-related education of investigators, study site personnel, and study staff.</li><li>
Has responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the asset.</li><li>
Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.</li><li>
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area</li><li>
Support database design and contribute to case report form (CRF) completion guidelines</li><li>
Educate internal study team members, clinical sites on protocol requirements.</li><li>
Collaborate with the Clinical Trial Manager (CTM) to support study start-up, conduct, and close-out activities</li><li>
Provide scientific input into vendor scope of work (SOW), contracts, and study charters</li><li>
Partner with vendors to ensure delivery of high-quality data and scientific integrity of services</li><li>
Perform ongoing clinical data review, including protocol deviations, to ensure data quality, accuracy, and scientific validity</li><li>
Identify data trends, summarize findings, and escalate clinical or medical concerns to the Medical Monitor as appropriate</li><li>
Review MedDRA and WHODRUG coding to ensure consistency and accuracy</li><li>
Represent Clinical Development on cross-functional study teams and at internal or external meetings</li><li>
May be asked to contribute to regulatory responses and discussions.</li><li>
Contribute to continuous improvement of clinical processes and study execution</li><li>
Perform other duties as assigned</li></ul>
What You'll Bring<ul><li>
Advanced degree in life sciences or a clinical field (e.g., RN, NP/ARNP, PharmD, Physician Assistant, PhD, MD, or equivalent) required</li><li>
Minimum of 2+ years of relevant experience in the biopharmaceutical industry or a comparable clinical research setting preferred</li><li>
Oncology experience strongly preferred</li><li>
Strong ability to interpret and analyze clinical data with a focus on scientific rigor</li><li>
Solid understanding of clinical development processes, GCP, and regulatory requirements</li><li>
Proficiency in medical terminology</li><li>
Demonstrated ability to assimilate complex scientific information quickly</li><li>
Excellent analytical, problem-solving, and critical thinking skills</li><li>
Strong written and verbal communication skills, with the ability to clearly convey scientific information</li><li>
Highly collaborative with the ability to work effectively in cross-functional teams</li><li>
Strong organizational skills, attention to detail, and commitment to data accuracy</li><li>
Ability to manage multiple priorities in a fast-paced environment and adapt to changing needs</li><li>
Proficiency with Microsoft Office Suite</li></ul>
Total Rewards
We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies. 
The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate&rsquo;s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience). 
Our total rewards package that includes:<ul><li>
Industry leading vacation and paid time off</li><li>
Exceptional medical, dental and vision benefits by country</li><li>
Zymelife health and wellness benefits</li><li>
Matching RRSP / 401K / Pension program</li><li>
Employee Share Purchase Program</li><li>
Employee Equity Program</li><li>
Paid time off to volunteer in your community</li></ul> 
This role is not eligible for relocation or immigration support. 
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability. 
NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract. 
The pay range for this role is: 
93,750 - 143,750 CAD per year(CA) 
97,500 - 149,500 USD per year(US)</div>

Clinical Scientist

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Discovery &amp; Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development &amp; Research &ndash; Non-MD
Job Category:
People Leader
All Job Posting Locations:
Irvine, California, United States of America
Job Description:
.
Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that&rsquo;s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for a Clinical Research Manager to support our Electrophysiology business. This role will work a Flex/Hybrid schedule with 2-3 days per week onsite in our Irvine, CA office. Remote candidates may also be considered.
Responsibilities:
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson &amp; Johnson, procedures and guidelines, this position:<ul><li>
Serves as a Clinical Research Manager within the Clinical R&amp;D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones</li><li>
Has oversight of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
</li><li>Manages and oversees ordering, tracking, and accountability of investigational products and trial materials;</li><li>
Ensures applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;</li><li>
Is responsible for team&rsquo;s interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel;
</li><li>Is responsible for clinical data review to prepare data for statistical analyses and publications;</li><li>
May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;</li><li>
In EMEA, responsible for Regulatory Affairs related tasks associated with clinical trials and evidence generation. (See ANNEX I &ndash; Regulatory Affairs Duties and Responsibilities);
</li><li>Contribute to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management, with collaborative relationships with all relevant Clinical R&amp;D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&amp;D, etc), ensuring cross-functional alignment;</li><li>
Ensures input and strong alignment from key regional Clinical R&amp;D leads and other strategically important countries/ regions in the development of the EGS/ EDS;</li><li>
Leads in study design to develop appropriate clinical trials to meet the clinical evidence needs;</li><li>
May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;</li><li>
Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.;</li><li>
Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);</li><li>
Plans, tracks and manages assigned project budgets to ensure adherence to business plans;
</li><li>Contributes in clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;</li><li>
Serves as the clinical representative on a New Product Development team;</li><li>
Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;</li><li>
Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;</li><li>
Is responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition;</li><li>
Manages and mentors resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency;</li><li>
Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;</li><li>
Is responsible for communicating business related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;</li><li>
Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;</li><li>
Should develop a strong understanding of the pipeline, product portfolio and business needs;</li><li>
Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed.</li><li>
May perform other duties assigned as needed;</li></ul>
Education<ul><li>
Minimum of a Bachelor&rsquo;s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.</li></ul>
Experience<ul><li>
A minimum of 8 years related scientific/ technical experience, including leadership/ management role within Clinical Research.</li><li>
Significant previous experience in clinical project leadership across multiple studies/ programs is required.</li><li>
Experience working well with cross-functional teams is required.</li><li>
Experience with budget planning, tracking and control is required.</li><li>
Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, &hellip;).</li><li>
Clinical/medical background is a plus.</li><li>
A minimum of 1-2 year people management related experience is a plus.</li><li>
Medical device experience is highly preferred.</li></ul>
Functional and Technical Competencies:<ul><li>
Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;</li><li>
Ability to provide scientifically strategic and scientific clinical research input across New Product Development and Life-Cycle Management projects, including complex and/ or transformational projects; Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;</li><li>
Strong presentation and technical writing skills;</li><li>
Strong written and oral English communication skills;</li><li>
Comprehensive understanding of clinical trial regulations across multiple regions;</li><li>
Demonstrates competencies in the following area are required:<ul><li>
Ability to lead teams to deliver critical milestones, including complex projects</li><li>
Strong project management skills with ability to handle multiple projects</li><li>
Strong people management skills</li><li>
Change agent in team development and progression</li></ul></li></ul>
Leadership Competencies:
Strong leadership required in alignment with J&amp;J Leadership Imperatives:<ul><li>
Connect &ndash; Develop strong collaborative relationships with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/ EDS. Create strong and productive partnership with resource providers and vendors.</li><li>
Shape - Make recommendations for and actively participate and lead in departmental process improvement activities. Through efficient use of resources, shape the way clinical trial management is conducted and resources are utilized.</li><li>
Lead - Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues.</li><li>
Deliver - Ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned.</li></ul>
Primary location for this position is Irvine, CA. At management discretion, the position may be performed remotely.
Ability to travel approximately 20-25% depending on the phase of the program.
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Clinical Data Management, Clinical Evaluations, Consulting, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Team Management
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 
 
Vacation &ndash;120 hours per calendar year 
 
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado &ndash;48 hours per calendar year; for employees who reside in the State of Washington &ndash;56 hours per calendar year 
 
Holiday pay, including Floating Holidays &ndash;13 days per calendar year 
 
Work, Personal and Family Time - up to 40 hours per calendar year 
 
Parental Leave &ndash; 480 hours within one year of the birth/adoption/foster care of a child 
 
Bereavement Leave &ndash; 240 hours for an immediate family member: 40 hours for an extended family member per calendar year 
 
Caregiver Leave &ndash; 80 hours in a 52-week rolling period10 days 
 
Volunteer Leave &ndash; 32 hours per calendar year 
 
Military Spouse Time-Off &ndash; 80 hours per calendar year 
 
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid</div>

Clinical Research Manager

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