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Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.
We are currently recruiting Technician II Pharmacy to join the Clinical Operations, internal Covance team, Leeds, UK. This is a full-time regular position.
We are looking for people interested in doing something different and working in laboratory with former working experience in clean room, biological safety cabinets or isolators.
Duties and Responsibilities:Assist with receipt, storage, packaging, disposition, and retention of Active Pharmaceutical Ingredients (API) and Investigational Medicinal Products (IMPs). Assist with maintenance and control of complete records with respect to API/IMP. Assist with dose preparation as appropriate. Assist with manufacturing/assembly/dispensing instructions and the generation of labels. Ensure the continued supply of any stock items. Maintain contact with any other organization that operates a supply function to pharmacy. Maintain an appropriate level of cleanliness and organization to the pharmacy. Ensure compliance with appropriate regulations and GMP/GCP requirements. Have understanding with all allocated protocols regarding API/IMP handling. Attend study meetings as appropriate. Assist the Pharmacist/Study Lead with Sponsor interaction. Assist with training of entry Pharmacy Technician. May be cross trained in study operations tasks. Education / Qualifications Qualified Pharmacy Technician BTEC National Diploma OR equivalent training certificate: NVQ/SQV National Certificate in Pharmaceutical Sciences Registered as a pharmacy technician with General Pharmaceutical Council (GPhC) Experience 2-4 years experience in hospital or industrial pharmacy OR 2 years experience in a GMP environment REQUIREMENT: 1-2 years of sterile, aseptic manipulation in a hospital or industrial environment (e.g. clean room within Grade A safety cabinets) A SIGNIFICANT PLUS: Any relevant clinical research experience would be an asset
Manager, Proposals, Budgets, Client Services, Leeds job. RFP, quotes, proposals, budgets, pricing. Clinical Pharmacology. Phase I clinical trials.
Thinking of accelerating your Client Services, Proposals & Budgets Manager career? Then think long-term and the extraordinary possibilities we can offer you at Covance.
We have helped the pharmaceutical industry develop:
More medicines worldwide than any other company, including the top 50 best-selling drugs on the market today, 100 % of all Oncology drugs approved in 2016.
With more than 350 beds at five sites across the United States and Europe, Covance is one of the largest early-stage clinical research organizations in the world.
Explore this Manager Client Services, Proposals & Budgets job with us and check for yourself why Covance is known to promote 2.5x more employees annually than the average company in the biopharmaceutical sector.
Due to the expansion of Covance´s Clinical Pharmacology Services, we are looking for our next Manager, Client Services (Proposals & Budgets).
Ideally based at our clinical research facilities in Leeds, we are prepared to offer home based flexibility to the right person (considering that regular presence at Leeds is needed for meetings, trainings, team work, etc.)
We will trust you to manage all aspects of quote, proposal and budget development for assigned opportunities, adhering to agreed-upon Business Unit specific and enterprise-wide proposal and pricing processes.
You will manage opportunities autonomously, establishing clear timelines, anticipating obstacles and providing solutions to meet client requirements.
You will review RFP/quote requests to ensure full understanding of client requirements and to ensure timely delivery of opportunities to clients.
This is a rich role, in which you will have the opportunity to collaborate with Operations, Finance, Sales Teams and others to compile award-winning proposal responses.
WHAT WE´LL OFFER YOU
Covance has been named among the World´s Most Innovative Companies in Forbes´ 2017 Ranking, and more than 90% of the top 20 global pharmaceutical companies are repeat customers… we can offer you not only a job, but a stable, long-term international career.
You will work cross-functionally, exposed to multiple teams, all of which can offer you venues for career progression and new directions (Sales, Operations, Finance, Legal…)Education / Qualifications
Bachelor’s Degree in a life science, business, finance or similar field.Experience
We are looking for someone bringing extensive direct experience in the CRO/biopharmaceutical environment, ideally involved with budgeting and proposal development for international Ph I-IV clinical trials.
You have excellent customer service skills, attention to detail and ability to be persistent while maintaining tact
Demonstrated computer skills – requires excellent MS Office experience (specifically Excel, Word, Outlook)
Demonstrated ability to plan, multi-task and prioritize, working to deadlines
Demonstrated teamwork, communication (written and verbal), and organizational skills
Proven ability to work independently
Ability to communicate appropriately and effectively with clients and Covance senior management
Do you have any questions about this job offer? Ask current employees.
Do you have any questions about this job offer? Ask current employees.
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Internships at Covance – office based, Leeds, United Kingdom
“Every day is another chance to help save the lives of millions of people around the world. When you join our team, you get to be a part of that.”
Who we are and what we do
We are a world-leading life sciences company offering laboratory testing and development services to the pharmaceutical industry across the globe.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. We put our trust in science and in one another. We believe that supportive teams, passionate people and inspired thinking are the formula for Better Science. This is your chance to become part of a team that helps to bring miracles of medicine to market sooner.
Covance is opening six (6) industrial placement opportunities in the Statistical Programming and Biostatistical fields (12 months duration). These are office based (Leeds) opportunities.
The SAS Programmer is responsible for executing programming activities in coordination with project teams with supervision. S/he will develop, create, verify/validate and maintain managing the programs for assigned projects in compliance with standard operating procedures.
Successful candidates will be given the opportunity to work in a busy, fast-paced environment within the SAS Programming group.In simple terms, you'll be involved in taking raw data from a clinical database, as well as from external vendors and, using SAS, convert this raw data into industry or client standard dataset formats, prior to using the datasets to create tables, figures and listing which present the data collected.
The Statistician is responsible for production and review of the randomization schedule, the statistical analysis plan, executing programming activities of statistical analysis and review of the clinical study report and tables, figures, listings, in coordination with project teams with supervision.
Additionally, you'll get help in developing a number of soft skills, for example; communication, scheduling, team-working, quality focus & deadline driven, taking the initiative and proactivity. It's also a great chance to experience a year in an office environment and learn from highly experienced team members.
In SAS Programming you will learn the following:Production of data tables, figures and listings (TFLs) to the required specification for clinical, PK and PD reports. This involves production of programs in SAS, to meet client specifications. How to reconcile electronic data with CRF data. How to create SDTM datasets. Good time management and organization skills, the ability to prioritize own work to meet tight deadlines while maintaining the highest standards of work. Effective communication skills; a co-operative and team orientated approach.
In Statistics you will learn the following:Generation of randomization schedules from provided specifications. Preparation of Statistical Analysis Plans (SAPs). Production of data tables, figures and listings (TFLs) to the required specification for clinical, PK and PD reports. This involves production of programs in SAS, to meet client specifications. Good time management and organization skills, the ability to prioritize own work to meet tight deadlines while maintaining the highest standards of work. Effective communication skills; a co-operative and team orientated approach.
What you'll receive
You'll undertake an Internship in SAS Programming or Statistics over the course of 12 months,A chance to work with lead industry experts, A chance to put theoretical skills in to practice and make a real impact in a global business, A chance to Act as an Ambassador across Yorkshire for Internships, A generous benefits and holiday package
The Recruitment process
We will receive applications until December 5th 2018, Wednesday If your CV is selected, the first step will be a phone interview with a member of the Covance Recruitment team Final step: personal interview at Covance offices in Leeds on December 12th or 13th 2018 Internship start date: July 1st, 2019.
Get ready to redefine what's possible and discover your extraordinary potential at Covance.
Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us as we speed the delivery of ground breaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients and your career.
Education / Qualifications
Minimum Criteria:Be studying for an Undergraduate degree in a Maths or Science Subject A willingness to learn, Great attention to detail, Good communication skills Experience Some (SAS) programming experience preferred.
Project Manager Clinical Pharmacology
The Covance Clinical Research Unit is located on the perimeter of the renowned Leeds General Infirmary and the University of Leeds. For over 30 years we have conducted a range of clinical pharmacology studies from first in human to registration enabling clinical trials, including drug-drug interaction, TQT, radiolabeled and microdosing studies. We also work in close partnership with local hospitals where our combined sites make a natural choice for first in human studies that combine both healthy volunteers and patients.
As Project Manager Clinical Pharmacology you will have the enviable opportunity to manage studies across multiple sites, working with a team of experts who truly appreciate the unique requirements for conducting Phase I studies in patients and ensuring the objectives of any small patient study are well understood and achieved.
The field of project management is evolving. Join our growing team and transform the way global project management is delivered.
Works independently or under direction of a more Senior Project Manager or Project Director on full service Covance clinic, external clinic projects with moderate complexity and moderate to high financial value. May serve as program level oversight for low complexity programs. Communicates on a regular basis with assigned clients regarding project needs and project status. Anticipates client needs. Facilitates and coordinates communication between client project team members and Covance project team members. Liaise with and lead a project team, including but not limited to Covance Site CRC, Data Management & Reporting team, CRA, external site contacts and vendors (both internal and external) regarding project specific requirements and scope. Serve as the escalation point for project or program issues. Provide feedback to line management on project team members and assist in conflict resolution as needed. Manages scope of the project by reviewing proposals and budgets, identification and submission of work scope changes against the project timelines, and on time delivery of project deliverables. Supports negotiations with client to ensure budget remains within contracted terms. Controls project margins and minimizes write offs. Contributes to proposal strategy, development, and may lead bid defense for assigned business development opportunities. Collaborate with finance when project milestones have been met to initiate monthly invoicing, and perform client follow up as appropriate. Manage client and departmental project metrics, maintain baseline information and assisting in the compilation of manual data. Develop mitigation plans where variance occurs. Performs overall management of the project timelines through use of MS Project and ensuring that changes or updates are made in a timely manner. Renegotiates timelines with client and project team as necessary. Track project metrics. Monitor and report on KPI for strategic relationships, actively managing to ensure they are within the scope of the contract. Assist in the development of strategic client metrics. Accountable for client eTMFs including eTMF Index & Plan, uploading project management documents, review and QCing of project documents and timely delivery of the eTMF per the agreed upon timelines. Monitor and control the risk plan and provide ongoing oversight to ensure mitigation plans are in place and working. Lead contingency plan implementation. Escalate risks newly identified by the project team to stakeholders. Ensure lessons learned are implemented across projects currently being managed and across the department as applicable. Initiate and drive improvements to enhance the efficiency and the quality of the work performed on assigned projects. Responsible for appropriate issue escalation to Covance’s CAPA and CAIR program and/or appropriate stakeholder(s). Drive timelines for successful completion of CAPA or CAIR. Organises, chairs, and ensures accurate documentation in meeting minutes for project meetings with client and team, as applicable. Completes and follows up on Action/Decision/Issues (ADI) items. Develop a thorough understanding of clinical, data management, reporting, and critical path activities. Present at external and/or internal meetings. Increase potential for repeat business by establishing a strong working relationship with the client project team striving for client satisfaction and operational excellence. In collaboration with relevant departments assist in the preparation and review of new proposals as required. Lead bid defense and performs other business development activities. May assist in the training and development of more junior and project team staff.
Education / Qualifications
University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution. Experience
Detailed knowledge of financial control procedures (i.e. earned value analysis) with an awareness and ability to actively utilize financial tracking systems. Working knowledge of project management processes Working knowledge of time and cost estimate development. Certified in Clinical Research – SOCRA/ACRP Certification
Covance is seeking a Principal Clinical Data Manager to work in their early phase department (Phase I and IIa) across numerous therapy areas. We are looking for very experienced Lead Clinical Data Managers who have programme level responsibility. Office based Leeds, Yorkshire or home based anywhere in UK. This an incredibly exciting time to be joining Covance as we continue to grow and expand.
Job Primary FunctionsLead Study Data Manager for studies which are highly complex including but not limited to - combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines As the study data lead/Client programme lead; be accountable for all DM deliverables as assigned per the established timeline Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as necessary Keep Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. budget status, work scope changes, timeline impacts) Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change processed Provides leadership, mentorship, and coaching Provide support to Data Management supervisors and managers on the performance evaluation of other team members; provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards Have input in writing, reviewing and updating SOPs and associated documents as required Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilize local laboratory systems and batch data load facilities where appropriate Represent Data Management and where necessary overall Biometrics in new business opportunities Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team Works with management team to develop and implement directional strategy by providing technical input into discussions, and rolling out training/mentorship to DM staff as required Actively represent Data Management at internal strategy calls, pricing review calls, and other meetings as required for scope/pricing decisions Education / Qualifications University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) Knowledge of effective clinical data management practices Fluent in English, both written and verbal Experience Ten years of combined early or late stage DM experience with four years of direct sponsor management and at least 2 years technical mentoring experience. Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies Time management skill and ability to adhere to project productivity metrics and timelines Ability to mentor junior members of the department, providing SME guidance on Data Management practices Experience of representing Data Management in bid defence meetings, providing innovative solutions to meet client needs Good organizational ability, communication and interpersonal skills Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events
PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE
NO AGENCIES PLEASE
MORE INFORMATION AVAILABLE ON REQUEST
For a confidential discussion about this opportunity, please phone Peter Lewis +44 (0) 1628 543 457.
As the drug development business of LabCorp and the world’s most comprehensive drug development service company, we have helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. Because of our broad experience and specialized expertise, we’re in a unique position to supply insights that go above and beyond testing. Together with our clients, we create solutions that transform potential into reality. For more information on Covance please visit: www.covance.com.
Medidata, RAVE, EDC, Electronic Data Capture, Lead Clinical Data Manager, Principal Clinical Data Manager, Programme Clinical Data Manager, Clinical Data Management, pharma, pharmaceutical, home based, field based, home-based, office based, UK, United Kingdom, England, Scotland, Wales, flexible location, Covance, Chiltern, CRO, Contract Research Organisation, Early Phase, Phase I, Phase II.