Thermo Fisher / PPD
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Summary of Essential Functions:
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Provides, under guidance, local regulatory strategy advice (MoH &/or EC) to internal clients.
Provides, under guidance local submission strategy. Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
Serves as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
Serves as a key-contact at the country level for either Ethical or Regulatory submission-related activities.
Coordinates, under guidance, internal department to align site start up activities with submission timelines.
May support country specific Informed Consent Form (ICF) negotiations with EC/IRB or RA and raise any country-level ICF risks to ICM and study leadership. Develop site-specific ICFs, manage ICF negotiations with EC/IRB, and document site ICF approvals.
Ensure guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
Participates as required in Submission Team Meetings, Review Meetings and Project Team meetings.
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieves PPD’s target cycle times for site activations.
May prepare the regulatory compliance review packages, as applicable.
Ensures that trial status information relating to SIA activities are accurately maintained in the database and is always current.
Oversees country study files and ensure that they meet PPD WPDs or client SOPs.
Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
May identify issues or anomalies in the regulatory process of a study and escalate as appropriate.
Under guidance, align with site on critical SSU path upon selection and maintain accountability for tracking of site critical path.
ED collection and review, submission of RCR packs, review and submission of all EDC packs, completion of Biogen Site Activation Form (SAF).
Ensure site staff complete vendor trainings and receive vender system access (e.g., IRT system, EDC, raters).
Ensures current investigator and site staff contact details are appropriately maintained in systems.
Drafts, executes and processes various company contracts, reports and related documents with clinical study sites and principal investigators.
Negotiates within approved parameters both investigator grant budget and contractual terms and conditions in accordance with client negotiation parameters, established process with clients and follows established escalation routes.
Coordinates stakeholder review of changes outside of negotiation parameters and submission of recommendation to resolve negotiations.
Monitors and reports contractual progress to Site Contract Manager.
Partners to reduce and/or eliminate company regulatory, legal and financial exposure.
Initiates and coordinates follow-up with stakeholders regarding the status of outstanding agreement issues in accordance with agreed process documents.
Tracks common negotiation points for negotiation parameter updates in accordance with agreed process documents.
Monitors investigator sites to ensure compliance and mitigate risks.
Ensures data accuracy through various monitoring activities.
Conducts and reports on monitoring visits in accordance with monitoring plan, protocol, ICH-GCP & local regulations, including confirmation and follow up letters.
Conducts physical inventory and records review of investigational products and associated pharmacy processes.
Documents observations in reports and letters using approved writing standards.
Escalates deficiencies to management (including CSL or CML as applicable) and follows through to resolution.
and follows through to resolution.
Responsible for initial and ongoing regulatory document amendments (e.g. ICFs) for assigned sites (per country feasibility based on scale).
Attend meetings to discuss site statuses to include but not limited to: study start up progress, trending and issue identification/escalation, and general site updates.
Submits documents to eTMF, ensures eTMF is up to date with site related documentation.
Assists TMF specialist with eTMF QC and issue resolution in accordance with agreed process.
Provide training and support to site staff on study protocols, procedures, and data collection methods.
Maintains regular site management contact with investigative sites to confirm protocol adherence, resolve issues, address queries, and ensure data entry compliance.
Participate in internal audits and inspections, ensuring that all study-related activities meet quality standards.
Conducts site feasibility assessments to evaluate the suitability and capability of potential sites for clinical trials, ensuring they meet the necessary requirements and standards.
Performs site selection visits to assess the site's facilities, staff qualifications, patient population, and overall capability to comply with the study protocol and regulatory requirements.
Participates in investigator meetings and assists in identifying potential investigators through the conduct of site selection activities.
Initiates clinical trial sites and ensures compliance with protocols and regulations.
Ensures trial closeout and retrieval of trial materials.
Ensures completeness of essential documents according to ICH-GCP and regulations.
Conducts on-site file reviews.
Provides trial status tracking and updates. Ensures accuracy and completeness of study systems, including IRT CTMS subject visit activities.
Facilitates effective communication between sites, client companies, and internal teams.
Completes administrative tasks promptly.
May contributes to project publications and shares ideas/suggestions with the team.
Facilitates effective communication among sites, client company, and PPD project team.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Completes administrative tasks promptly.
Contributes to project work and process improvement initiatives as required.
Education and Experience:
Other: