Lediga jobb Pra International Sweden AB Lund

Clinical Team Manager (COM)

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We are looking for a homebased Clinical Trial Manager (COM) who is accountable for performance and compliance for assigned protocols in Sweden in compliance with IC H/GCP and Swedish regulations, sponsor policies and procedures, quality standards. Furthermore, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure site readiness. Responsibilities Responsibilities i... Visa mer

We are looking for a homebased Clinical Trial Manager (COM) who is accountable for performance and compliance for assigned protocols in Sweden in compliance with IC H/GCP and Swedish regulations, sponsor policies and procedures, quality standards. Furthermore, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure site readiness.
Responsibilities
Responsibilities include, but are not limited to:
· Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements '
· Oversight of study finance- Payments, reconciliation, maintenance of financial systems and in conjunction with Project Manager participate in financial forecasting.
· Responsibility for creation and execution of clinical trial country submissions and approvals for assigned protocols.
· Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
· Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
· Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
· Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
Qualifications
· At least 5 years experience in Clinical Research or combined experience in Clinical Research and Finance/Business
· Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
· Expertise of core clinical systems, tools and metrics
· Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
· Strong understanding of Swedish regulatory environment required
· Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in Swedish and English.
· Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
· Right to live and work in Sweden we do not sponsor work permits for this role. Visa mindre

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Site Management Associate - Study Start Up

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SINGLE SPONSOR, EMBEDDED SITE MANAGEMENT ASSOCIATE - STUDY START UP ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save... Visa mer

SINGLE SPONSOR, EMBEDDED SITE MANAGEMENT ASSOCIATE - STUDY START UP

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
We are looking for a homebased Site Management Associate to be work with our sponsor, a global biotechnology company dedicated to revolutionizing cancer care.
This in-house position is responsible for supporting site start-up activities, including collection and review of essential documents, and reviewing and approving ICFs (Informed Consent Forms) for IRB/IEC submissions for assigned clinical sites.
Responsibilities include, but are not limited to:
Accountable for site start-up for assigned clinical sites
Serves as site’s primary point of contact for start-up, resolving site queries and assisting sites with IRB/IEC submissions
Sends start-up packets
Reviews and approves ICFs pre- and post-IRB/IEC submission
Collects, reviews, approves, and tracks essential documents, and reviews and approves ICFs in accordance with Seagen processes and timelines
Assists in resolution of site queries for assigned clinical sites
Provides regular updates and escalates site issues to SSU Manager
May attend weekly start-up meetings with SSU Manager, PL, CCM, Legal, and other key stakeholders as necessary
Forecasts and tracks metrics and progress of site start-up for assigned clinical sites, ensuring all sites are greenlit on time per SSU timelines
Ensures metrics in clinical trial management systems are up to date and accurate
Ensures site essential documents are uploaded to eTMF accurately and on time for site greenlight
Prepares greenlight packets for assigned clinical sites
Performs second review of essential documents and/or ICFs for other members of the SSU team
Mentors junior SSU Team members
Manages time on assigned clinical sites across one or more clinical studies, and escalates issues to SSU Manager

Here at ICON, we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
3 – 5 Years of Pharmaceutical/Biotech Industry experience
Previous start up unit experience
Knowledge of clinical start-up process and requirements
Knowledge of CFR and GCP/ICH requirements
Fluent in Swedish
Effective organizational and time management skills
Able to multi-task under limited direction and on own initiative
Strong communication and inter-personal skills
Highly responsive and proactive, a team player
Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint Visa mindre

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Clinical Research Associate - Strategic Solutions

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We are looking for a homebased Clinical Research Associate (CRA), to work with a single sponsor fully outsourced to their team. The Clinical Research Associate is ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical studies throughout the trial lifecycle. Key responsibilities include: Full ownership of investigator sites for assigned studies, with responsibility for the successful mana... Visa mer

We are looking for a homebased Clinical Research Associate (CRA), to work with a single sponsor fully outsourced to their team.
The Clinical Research Associate is ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical studies throughout the trial lifecycle. Key responsibilities include:

Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines.

You will receive the support you need to develop personally and professionally and work in an environment where you matter. This sponsor is unique in that you will be treated as a full member of their global Clinical Trials Team. As a CRA, you play a key role in our sponsor’s drug development process and are expected to push forward together - united in solving problems, developing close site relationships and reaching the end goal.
Qualifications
To enable success in this position you will have:
At least 1 year of experience working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
Experience working on Oncology trials or complex studies would be an advantage for this role.
A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential
Fluency in Swedish and English is essential
You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.
We have a number of roles open. Homebased in Stockholm, Mälardalen (Uppsala preferred) and Southern Sweden (Gothenburg/Lund/Malmö) Visa mindre

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Lediga jobb Pra International Sweden AB i Lund

Clinical Team Manager (COM)

Site Management Associate - Study Start Up

Clinical Research Associate - Strategic Solutions