Local Delivery Lead (US Clinical Trial Manager) at GSK in Philadelphia, PA
GSK is looking for a Clinical Trial Manager to join our team. As the Clinical Trial Manager, you will be responsible for the operational planning and delivery of Phase I-IV clinical trials in the US LOC (United States). You will provide oversight and manage activities across all therapy areas (Pharma&Vaccines) to the requiredquality standards, GSK written standards, local regulations and ICH GCP. Key
Responsibilities:
o Leads the local study team (US) consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project management of study activities within the country. o The Clinical Trial Manager collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements. o Serves as the operational point-of-contact between the central GSK study team and within country (US LOC) study team. o As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within country. o Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPS and POLs. o Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity. o Ensures that critical study timelines related to study activities within-country are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. o Accountable for the accuracy of study systems, including completeness of the trialmaster file, and reporting study delivery progress to study team and key stakeholders. o Identifies and resolves or escalates issues and risks that may impact study delivery. Takes a leadership role in identifying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level. o Provides feedback on performance, capabilities and competencies of study members to line management. o Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility. o As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites. o As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study. o Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of disease area being studied, competitive landscape within the country o As required, assists with audits/inspections of local clinical operations department and study / sites in the country. Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
o Bachelor's degree o 5 or more years of industry project management experience o Experience with end to end delivery of clinical trials Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
o Advanced Degree in Life Sciences o Infectious Disease, Oncology, or Vaccinesexperience o Strong stakeholder management experience o Proven ability to influence and build consensus
Salary Range:
$80K -- $100K
Minimum Qualification
Business Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
o Leads the local study team (US) consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project management of study activities within the country. o The Clinical Trial Manager collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements. o Serves as the operational point-of-contact between the central GSK study team and within country (US LOC) study team. o As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within country. o Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPS and POLs. o Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity. o Ensures that critical study timelines related to study activities within-country are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. o Accountable for the accuracy of study systems, including completeness of the trialmaster file, and reporting study delivery progress to study team and key stakeholders. o Identifies and resolves or escalates issues and risks that may impact study delivery. Takes a leadership role in identifying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level. o Provides feedback on performance, capabilities and competencies of study members to line management. o Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility. o As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites. o As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study. o Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of disease area being studied, competitive landscape within the country o As required, assists with audits/inspections of local clinical operations department and study / sites in the country. Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
o Bachelor's degree o 5 or more years of industry project management experience o Experience with end to end delivery of clinical trials Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
o Advanced Degree in Life Sciences o Infectious Disease, Oncology, or Vaccinesexperience o Strong stakeholder management experience o Proven ability to influence and build consensus
Salary Range:
$80K -- $100K
Minimum Qualification
Business Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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