Ref #: 40854
Employment type: Permanent - Full-Time
Location: Denmark - Home-based
Posted: 24-Mar-2023
Description
We have a great opportunity for an experienced clinical trial manager to join a growing and successful team, sponsor dedicated. This is a permanent and home-based position where you will be managing the CRAs for their delivery of the clinical trials on a country/regional level.
Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulations.
Maintains the quality and scientific integrity of clinical trials at a country level.
Collaborates with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the country.
Maintains expert country, site and protocol knowledge to support sites with questions as well as build strong site relationships.
Partners with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery.
Accountable for study deliverables and drives key decisions within set country.
Responsibilities:
Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
Supports country-level operational planning and accountable for site selection within assigned country/-ies.
Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.
Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers, Program Managers, Development Operations Manager etc) with oversight as required and ensures updates to relevant systems.
Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.
Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training.
Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.
Engages with local cluster team and local functions from a study perspective (e.g., Local Medical Affairs team).
Qualification and experience required:
Science degree
Experienced clinical trial project management experience
Experience in study management and submissions on a country level.
Strong work experience in life sciences or medically related field, biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
Must be a local/country expert with identifiable project management experience locally
Builds strong site relationships as well as other local relationships to ensure end to end study delivery is met.
To apply:
Would you like to know more? We are looking forward to your application by submitting your CV via email to anja.potrafke@docsglobal.com. We are looking forward to hearing from you.
Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulations.
Maintains the quality and scientific integrity of clinical trials at a country level.
Collaborates with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the country.
Maintains expert country, site and protocol knowledge to support sites with questions as well as build strong site relationships.
Partners with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery.
Accountable for study deliverables and drives key decisions within set country.
Responsibilities:
Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
Supports country-level operational planning and accountable for site selection within assigned country/-ies.
Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.
Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers, Program Managers, Development Operations Manager etc) with oversight as required and ensures updates to relevant systems.
Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.
Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training.
Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.
Engages with local cluster team and local functions from a study perspective (e.g., Local Medical Affairs team).
Qualification and experience required:
Science degree
Experienced clinical trial project management experience
Experience in study management and submissions on a country level.
Strong work experience in life sciences or medically related field, biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
Must be a local/country expert with identifiable project management experience locally
Builds strong site relationships as well as other local relationships to ensure end to end study delivery is met.
To apply:
Would you like to know more? We are looking forward to your application by submitting your CV via email to anja.potrafke@docsglobal.com. We are looking forward to hearing from you.