Clinical Operations Manager
il y a 2 semaines
Clinical Operations Manager (COM)
FSPX
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Labcorp Drug Development client’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
Essential Job Duties
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles.
- Executes and oversees 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.
- Contributes to the development of local SOPs. Oversees CTCs as applicable.
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborates closely with Headquarter to align country timelines for assigned protocols.
- Provides support and oversight to local vendors as applicable.
- 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.
- Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- 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.
Experience
- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
Education/Qualifications/Certifications and Licenses
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- Expertise of core clinical systems, tools and metrics
- Excellent English skills
- Strong coordination and organizational skills
- Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-ups
- Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with mínimal support from the SCOM or manager.
- Ability to make decisions independently with limited oversight from SCOM or manager.
- Requires strong understanding of local regulatory environment
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
-
Clinical Operations Manager
il y a 4 jours
Sint-Lambrechts-Woluwe, Belgique Labcorp Temps pleinThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, the business client’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for...
-
Clinical Trials Budget Manager
il y a 5 jours
Sint-Lambrechts-Woluwe, Belgique Care4You Temps pleinOur client is an international association in the field of medical research. They coordinate clinical trials worldwide in partnership with their 50+ member organisations. Their Brussels office gathers +/- 40 staff and is located in Woluwe-Saint-Lambert. They are today looking for a diligent Clinical Trials Budget Manager to work as part of their closely knit...
-
Project Manager Start-up
il y a 6 jours
Sint-Lambrechts-Woluwe, Belgique Labcorp Temps pleinThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Labcorp Drug Development client’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for...
-
Operations Manager
il y a 4 semaines
Sint-Niklaas, Belgique inHouse Temps plein**Operations manager**: Ontwikkel de toekomstvisie van de nieuwe site en realiseer een ongekende groei **Supply Chain** **inHouse** **Sint-Niklaas** **Beschrijving**: CHOCOLATE - Als Operations manager kom je terecht bij een vooruitstrevende dochteronderneming van een toonaangevend bedrijf in de chocoladewereld. Bij de allernieuwste productiesite van de...
-
Front Office Manager
il y a 1 semaine
Sint-Lambrechts-Woluwe, Belgique Tangla Hotel Brussels Temps pleinA Front Office Manager is responsible for supervising the support staff, managing the first impressions of our Guests and, therefore, must perform the following tasks to the highest standards: - Oversee the entire Front Office operation to maintain high standards. - Showing initiative, Problem solving, Team leading. - Evaluate levels of Guest satisfaction...
-
Operations Manager Logistics Operations
il y a 2 semaines
Sint-Truiden, Belgique AGO Jobs & HR Temps pleinJe zoekt een toffe job? Tijdelijk of (optie) vast? Als arbeider of bediende? Kom dan zeker langs in een van onze 80 kantoren of surf naar www.ago.jobs. Wij hebben meer dan 3500 openstaande vacatures voor jou en helpen jou graag een job te vinden die bij jou past. Choose life, choose work, choose AGO! Functieomschrijving Als Operations Manager Logistics...
-
Shop Manager Woluwe Cora
il y a 3 semaines
Sint-Lambrechts-Woluwe, Belgique TUI Temps pleinEn tant que responsable de magasin TUI, vous organiserez les opérations quotidiennes de votre magasin TUI. **A propos du Job** - Vous appliquerez le concept TUI Shop en termes de look & feel ainsi que les aspects commerciaux et opérationnels pour une expérience client optimale/TUI Experience. - Vous participerez activement au processus de vente...
-
Kitting and Packaging Officer
il y a 4 semaines
Sint-Stevens-Woluwe, Belgique Actief Interim Temps pleinFor a medical company in Zaventem we’re looking for Kitting and Packaging officers. Being precise and accurate is needed as these packages are important to be packed sterile and ready to use.Responsibilities: - Ordering, receiving, processing and storing of laboratory supplies. - Shipment and delivery, return drug accountability, reconciliation an...
-
Human Resources Manager for Belgium
il y a 5 jours
Sint-Lambrechts-Woluwe, Belgique Aspria Belgium Temps pleinFunctieomschrijving As HR Manager, you are responsible to deliver a fully comprehensive generalist HR service in line with the Group HR and Business strategy, policy and legal requirements. With the support of 2 HRBP and 1 recruiter, you are in charge of the delivery of HR objectives and goals and to business partner with the General Managers to ensure each...
-
Human Resources Manager for Belgium
il y a 4 jours
Sint-Lambrechts-Woluwe, Belgique Aspria Belgium Temps pleinFunctieomschrijving As HR Manager, you are responsible to deliver a fully comprehensive generalist HR service in line with the Group HR and Business strategy, policy and legal requirements. With the support of 2 HRBP and 1 recruiter, you are in charge of the delivery of HR objectives and goals and to business partner with the General Managers to ensure each...
-
Assistent Operations Manager
il y a 4 jours
Sint-Niklaas, Belgique Actief Interim Temps pleinVoor onze opdrachtgever - een dynamisch bedrijf te Sint-Niklaas die op enkele jaren tijd een sterke groei wist te realiseren zonder daarbij haar familiale karakter uit het oog te verliezen - selecteren we een assistent operationeel manager om de verdere uitbouw van de onderneming te faciliteren en de veranderingsprocessen te verankeren binnen de...
-
Operations Manager
il y a 4 semaines
Sint-Jans-Molenbeek, Belgique Nohau Temps pleinFunctieomschrijving Voor onze klant in Zellik zijn wij op zoek naar een Operations Manager in de nachtploeg: - Efficiënt organiseren en managen van de operationele activiteiten en monitoren van performantiegegevens. - Efficiënt plannen en inzetten van medewerkers - Coördineren van onderhoudsactiviteiten binnen het distributiecentrum - Motiveren,...
-
Operations Manager fruitpluk
il y a 4 semaines
Sint-Truiden, Belgique Glowi Jobs Temps pleinTaakbeschrijving In 1979 begon Elko Fruits met zijn eerste plantage in Sint-Truiden. Doorheen de jaren is Elko Fruit uitgegroeid tot een groot fruitbedrijf van 150 ha met een eigen koelinstallatie en sorteerafdeling. Met de volgende generatie ook ondertussen mee aan het roer van het bedrijf dat gespecialiseerd is in de teelt van appelen, peren en kersen. Ook...
-
Operations Manager
il y a 5 jours
Sint-Truiden, Belgique Callexcell Temps pleinWe zoeken momenteel naar een ervaren Operations Manager voor Callexcell. Het stimuleren van de persoonlijke groei en ontwikkeling van team coaches is een belangrijk aspect van je functie. Je bent verantwoordelijk voor het behalen van kwalitatieve doelstellingen om de tevredenheid van externe opdrachtgevers te waarborgen. Dit draagt bij aan een duurzaam...
-
National Business Developer
il y a 1 semaine
Sint-Lambrechts-Woluwe, Belgique ManpowerGroup Belgium Temps plein**Client Description**: ManpowerGroup® de wereldwijde leider in Global Workforce Solutions, helpt organisaties bij hun transformatie in een snel veranderende wereld van werk door het talent dat hen in staat stelt te winnen, te sourcen, beoordelen, ontwikkelen en beheren. We ontwikkelen elk jaar innovatieve HR-oplossingen voor honderdduizenden organisaties...
-
LEAD OPERATIONS
il y a 1 semaine
Woluwe-Saint-Pierre, Belgique Profile Group Temps pleinLa société...
-
Administrative Assistant English/german
il y a 4 jours
Sint-Stevens-Woluwe, Belgique Actief Interim Temps pleinFor a major medical company specialised in clinical research we are looking for a Dutch speaking inverstigator service asstistant. You will be responsible for the overall performance, education and training of the sites to ensure that protocols are completed accurately and on time.The Investigator Services Assistant provides support to investigator sites,...
-
Director, Expo Operations, Emea
il y a 2 jours
Sint-Joost-ten-Node, Belgique IAAPA EMEA Temps plein**Department/Office** Sales and Operations / EMEA **Reports To** Head of Global Expo Operations, with a dotted line to the Regional Executive Director & Vice President **Direct Reports** None **Overall Responsibilities** The Director, Expo Operations, EMEA is primarily focused on exhibitor and attendee services at IAAPA Expo Europe including...
-
Assistant Manager Operations
il y a 4 semaines
Sint-Gillis-Waas, Belgique AGO Jobs & HR Temps pleinJe zoekt een toffe job? Tijdelijk of (optie) vast? Als arbeider of bediende? Kom dan zeker langs in een van onze 80 kantoren of surf naar www.ago.jobs. Wij hebben meer dan 3500 openstaande vacatures voor jou en helpen jou graag een job te vinden die bij jou past. Choose life, choose work, choose AGO! Functieomschrijving Je bent de co-piloot van ons...
-
Food & Beverage Supervisor
il y a 4 semaines
Sint-Lambrechts-Woluwe, Belgique Tangla Hotel Brussels Temps plein: Assist the Food and Beverage Manager to direct and organize the Food & Beverage function within the hotel to maintain high standards of food and beverage quality, service, and merchandising to maximize profit. Ensure the smooth running of the food and beverage offer throughout the Hotel. You will have the responsibility to develop, innovate and deliver a...